FDA Registration
Active
🇩🇪 Germany
TEKNO MEDICAL OPTIK-CHIRURGIE GMBH
Reg #: 9611503
·
FEI: 3002808335
·
Expires 2026
Products
146
Proprietary Names
7
Establishment Types
3
Classifications
146
Registration Details
- Registration Name
- TEKNO MEDICAL OPTIK-CHIRURGIE GMBH
- Registration Number
- 9611503
- FEI Number
- 3002808335
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SATTLERSTRASSE 11
- City
- TUTTLINGEN-Nendingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K981919
Owner / Operator
- Firm Name
- TEKNO-MEDICAL OPTIK-CHIRURGIE GMBH
- Operator Number
- 10027774
- Address
- Sattlerstrasse 11
- City
- Tuttlingen
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
- Correspondent
- FLORIAN MATTES
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 |
|---|---|---|---|---|---|
| Hysteroscope Accessories | NWW | Class 1 | Obstetrics/Gynecology | No | 2008-12-02 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 2017-10-25 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-06-09 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2025-01-16 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2025-01-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Applicator, Vaginal | HGD | Class 1 | Obstetrics/Gynecology | No | 2013-05-22 |
| Apron, Leaded | EAJ | Class 1 | Radiology | No | 2008-12-02 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-02-09 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2011-03-15 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2016-09-20 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2008-12-02 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2008-12-02 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-06-09 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2009-11-12 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2008-12-02 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 2010-03-29 |
| Light Source, Endoscope, Xenon Arc | GCT | Class 2 | Gastroenterology, Urology | No | 2015-02-06 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Razor, Surgical | LWK | Class 1 | General, Plastic Surgery | No | 2009-12-01 |
| Apparatus, Suturing, Stomach And Intestinal | FHM | Class 1 | General, Plastic Surgery | No | 2010-06-23 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2008-12-02 |
| Bistoury, Tracheal | KCC | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2013-01-30 |
| Catheter, Continuous Irrigation | GBQ | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2008-12-02 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-04-30 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2008-12-02 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2016-06-09 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2016-06-09 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2008-12-02 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2008-12-02 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2008-12-02 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Light, Surgical Headlight | EBA | Class 1 | Dental | No | 2010-03-01 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2008-12-02 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2008-12-02 |
| Mediastinoscope, Surgical | EWY | Class 2 | Ear, Nose, Throat | No | 2015-01-30 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2025-03-20 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2008-12-04 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2010-04-23 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2008-12-02 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2008-12-02 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2008-12-02 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 2008-12-02 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2008-12-02 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2015-01-29 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2008-12-02 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2014-08-20 |
| Spreader, Bladder Neck | FHK | Class 1 | Gastroenterology, Urology | No | 2008-12-02 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2010-03-19 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2008-12-02 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2008-12-02 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2018-04-17 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2008-12-02 |
| Evacuator, Bladder, Manually Operated | FFD | Class 1 | Gastroenterology, Urology | No | 2008-12-02 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2008-12-02 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Carrier, Ligature | GEJ | Class 1 | General, Plastic Surgery | No | 2010-03-19 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2008-12-02 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2008-12-02 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2008-12-02 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2018-12-18 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2008-12-02 |
| Lamp, Operating-Room | FQP | Class 2 | General, Plastic Surgery | No | 2015-02-05 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2008-12-02 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2012-04-30 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2008-12-02 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2008-12-02 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2016-06-09 |
| Pinwheel | GWY | Class 1 | Neurology | No | 2008-12-02 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 2013-07-15 |
| Dislodger, Stone, Flexible | FGO | Class 2 | Gastroenterology, Urology | No | 2017-01-16 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2008-12-02 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2015-02-05 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2008-12-02 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2008-12-02 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2008-12-02 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2008-12-02 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2008-12-02 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2008-12-02 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 2008-12-02 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2008-12-02 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2010-03-19 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2008-12-02 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2008-12-02 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2008-12-02 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2008-12-02 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2022-07-20 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2008-12-02 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2010-01-25 |
| Urethrotome | EZO | Class 2 | Gastroenterology, Urology | No | 2025-03-20 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2015-11-20 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2009-04-09 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2008-12-02 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2025-02-28 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2008-12-02 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 2008-12-02 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
| Blower, Powder, Ent | KCL | Class 1 | Ear, Nose, Throat | No | 2009-01-22 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2008-12-02 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2008-12-02 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2008-12-02 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2008-12-02 |
Proprietary Names
Head Mirror
VISUAL OBTURATOR FOR HYBRID RESECTOSCOPE
Atria 1 (LED, Single Color)
Atria 2 (LED, Single Color)
Atria 3 (LED, Single Color)
Atria 5 (LED, Single- / Multicolor)
Atria 7 (LED, Single- / Multicolor)
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)