FDA Registration
Active
🇩🇪 Germany
RZ MEDIZINTECHNIK GMBH
Reg #: 9680718
·
FEI: 3000280067
·
Expires 2026
Products
191
Proprietary Names
34
Establishment Types
3
Classifications
191
Registration Details
- Registration Name
- RZ MEDIZINTECHNIK GMBH
- Registration Number
- 9680718
- FEI Number
- 3000280067
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- UNTER HASSLEN 20/22
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K130778
Owner / Operator
- Firm Name
- RZ MEDIZINTECHNIK GMBH
- Operator Number
- 9010855
- Address
- Unter Hasslen 20/22
- City
- Tuttlingen
- State
- Baden-Wurttemberg
- Postal Code
- D-78532
- Country
- DE
- Correspondent
- Tanja Weggler
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 1999-04-15 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1995-08-10 |
| Laryngoscope, Endoscope | GCI | Class 2 | Gastroenterology, Urology | No | 2010-01-13 |
| Probe | HXB | Class 1 | Orthopedic | No | 2009-02-12 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2009-03-19 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2023-08-31 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2009-06-05 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2014-12-16 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 1996-02-09 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 1997-07-11 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2019-04-05 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2019-04-05 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2005-09-28 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2008-07-27 |
| Cable | ISN | Class 1 | Physical Medicine | No | 2005-05-03 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2003-12-22 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2014-12-16 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1996-04-01 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2006-10-10 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2010-02-24 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2014-12-15 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2009-02-18 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2014-12-16 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2005-09-28 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2014-12-15 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 1997-05-12 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 1996-03-07 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2008-09-17 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1996-03-18 |
| Adaptor, Ureteral Catheter | EYI | Class 1 | Gastroenterology, Urology | No | 2023-08-31 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1995-09-27 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2014-12-16 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2014-12-13 |
| Headlight, Fiberoptic Focusing | FCT | Class 2 | Ophthalmic | No | 2016-09-21 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 1996-02-09 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1995-09-20 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2006-10-10 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 1995-07-27 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1998-01-06 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 1995-12-20 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2009-06-05 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2008-07-27 |
| Bougie, Urological | FAX | Class 1 | Gastroenterology, Urology | No | 2005-09-28 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2009-01-07 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1995-11-29 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 1996-01-16 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 1998-05-15 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2008-07-27 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2014-12-15 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2014-12-16 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2014-12-15 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2003-10-03 |
| Probe, Trabeculotomy | HNK | Class 1 | Ophthalmic | No | 2009-06-03 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1999-10-28 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2009-06-03 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2006-10-10 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 1997-12-03 |
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2010-07-07 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1995-09-27 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2006-10-10 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 2003-10-03 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2006-10-10 |
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2023-08-31 |
| Brace, Drill | HXY | Class 1 | Orthopedic | No | 1997-07-11 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-12-17 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 1998-01-05 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 1995-10-12 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2021-12-06 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2009-02-12 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2008-07-27 |
| Connector, Ureteral Catheter | EYK | Class 1 | Gastroenterology, Urology | No | 2023-08-31 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 1995-08-03 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2005-09-28 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 1995-09-25 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 1995-09-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2009-02-18 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2010-02-24 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2008-07-27 |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | Class 1 | Obstetrics/Gynecology | No | 2014-12-17 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2005-09-28 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 1995-07-27 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 1995-07-20 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2023-08-31 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1995-12-19 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 2005-09-28 |
| Catheter, Cholangiography | GBZ | Class 1 | General, Plastic Surgery | No | 2008-07-27 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2009-06-05 |
| Curette, Ethmoid | KAO | Class 1 | Ear, Nose, Throat | No | 2014-12-16 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2010-02-24 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2023-08-31 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2006-10-10 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2014-12-17 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2014-12-16 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2010-02-24 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2006-10-10 |
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2009-03-20 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 1996-10-29 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2009-06-05 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1996-03-05 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2014-12-14 |
| Clamp, Uterine | HGC | Class 1 | Obstetrics/Gynecology | No | 1996-01-16 |
| Sound, Urethral, Metal Or Plastic | FBX | Class 1 | Gastroenterology, Urology | No | 2014-12-14 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1995-09-11 |
| Spreader, Bladder Neck | FHK | Class 1 | Gastroenterology, Urology | No | 2010-02-24 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2009-05-30 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2014-12-16 |
| Lithotriptor, Biliary Mechanical | LQC | Class 2 | Gastroenterology, Urology | No | 2025-07-08 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 1996-02-27 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 1998-12-30 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2023-08-31 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1995-08-16 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2006-10-10 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1995-12-26 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2023-08-31 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1994-07-05 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2009-02-18 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2014-12-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1995-09-25 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2006-10-10 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2006-10-10 |
| Rongeur, Lachrymal Sac | HNG | Class 1 | Ophthalmic | No | 2009-06-03 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2019-04-05 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1997-08-06 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2023-08-31 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2014-12-15 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2008-11-17 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2016-06-09 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1996-03-19 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 1995-07-10 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2014-12-15 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2010-02-24 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2006-10-10 |
| Gauge, Lens, Ophthalmic | HLN | Class 1 | Ophthalmic | No | 1995-10-23 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1996-12-04 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2006-10-10 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2009-06-05 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 1996-07-26 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2005-09-28 |
| Light, Surgical, Endoscopic | FSW | Class 2 | General, Plastic Surgery | No | 2023-08-31 |
| Punch, Skull | GXJ | Class 1 | Neurology | No | 2014-12-15 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1996-01-16 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 1995-09-18 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2010-02-24 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 1997-05-15 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2003-10-03 |
| Table, Operating-Room, Manual | FSE | Class 1 | General, Plastic Surgery | No | 2009-02-12 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2010-05-12 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2006-10-10 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 2014-12-17 |
| Stand, Instrument, Ophthalmic, Non-Powered | HMG | Class 1 | Ophthalmic | No | 2009-06-02 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2009-06-05 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 1995-09-25 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2006-10-10 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 1997-04-04 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 2005-09-28 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2013-07-30 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2014-12-16 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 1999-05-07 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1995-10-12 |
| Trocar, Gastro-Urology | FBQ | Class 2 | Gastroenterology, Urology | No | 2023-08-31 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2005-09-28 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2009-06-05 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2014-12-15 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2006-10-10 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2014-12-16 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1995-01-11 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2014-12-15 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2014-12-15 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1995-09-20 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2005-09-28 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2009-06-05 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2016-09-20 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2006-10-10 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2008-07-27 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 1995-07-27 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1995-08-30 |
| Hook, Gastro-Urology | FHB | Class 1 | Gastroenterology, Urology | No | 2014-12-14 |
| Catheter, Pediatric, General & Plastic Surgery | GBN | Class 1 | General, Plastic Surgery | No | 2005-09-28 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2014-12-16 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 1995-07-27 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 1995-08-03 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 1997-05-01 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2005-09-28 |
| Expressor | HNS | Class 1 | Ophthalmic | No | 2009-06-05 |
| Burr, Corneal, Battery Powered, Rust Ring Removal | OHW | Class 1 | Ophthalmic | No | 2009-06-05 |
| Pen, Marking, Surgical | HRP | Class 1 | Ophthalmic | No | 2009-06-05 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2010-07-07 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2014-12-17 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 1995-09-27 |
| Snare, Enucleating | HNE | Class 1 | Ophthalmic | No | 2009-06-03 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2005-09-28 |
Proprietary Names
Hemostat
Marker
Mouth Gag
Hook
Knife
Mallet
Needle
Speculum
Container
Cannula
Forceps
Curette
RZ Lithotriptor
351-100-500
scissors
Retractor
351-116-535
351-116-537
Gauge
Dissector
Silicone Valve
Tray
Rubber seal
Suture Passer Needle, disposible
300-400-751
300-660-010
300-750-105
300-400-753
300-660-005
Chisel
Elevator
Punch
Rasp
RZ Resectocope System, Electrodes and Accessories
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility