FDA Registration
Active
🇩🇪 Germany
HELMUT ZEPF MEDIZINTECHNIK GMBH
Reg #: 9611367
·
FEI: 3002807169
·
Expires 2026
Products
96
Proprietary Names
0
Establishment Types
4
Classifications
96
Registration Details
- Registration Name
- HELMUT ZEPF MEDIZINTECHNIK GMBH
- Registration Number
- 9611367
- FEI Number
- 3002807169
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- OBERE HAUPTSTR. 16-20
- City
- SEITINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K092855
Owner / Operator
- Firm Name
- HELMUT ZEPF MEDIZINTECHNIK GMBH
- Operator Number
- 8010277
- Address
- OBERE HAUPTSTR. 16-20, --
- City
- SEITINGEN
- State
- DE-NOTA
- Postal Code
- D-78606
- Country
- DE
- Correspondent
- PATRICK - ZEPF
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 |
|---|---|---|---|---|---|
| Remover, Crown | EIS | Class 1 | Dental | No | 1996-05-29 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 1992-09-29 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2013-01-30 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2011-11-08 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 1989-09-08 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2013-02-28 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2017-01-12 |
| Probe | HXB | Class 1 | Orthopedic | No | 1997-10-27 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 1997-10-27 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2013-01-08 |
| Awl | HWJ | Class 1 | Orthopedic | No | 1997-06-19 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2013-01-31 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 1989-09-08 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 1997-10-27 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 1996-05-29 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 1989-09-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-01-12 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 2013-01-30 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2013-11-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-01-08 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 1996-05-29 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 1996-05-29 |
| Screw, Fixation, Intraosseous | DZL | Class 2 | Dental | No | 2013-01-08 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1989-05-23 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 1997-10-27 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2013-07-19 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2001-10-23 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2017-01-12 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 1997-06-19 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-02-28 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1997-06-19 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2013-01-30 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2013-01-31 |
| Bur, Dental | EJL | Class 1 | Dental | No | 1998-09-04 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 1996-05-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2012-12-18 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 1996-06-05 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2011-09-06 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2011-11-05 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2004-10-20 |
| Curette, Operative | EKE | Class 1 | Dental | No | 2013-01-31 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 1989-09-08 |
| Bar, Preformed | EHO | Class 1 | Dental | No | 1992-09-29 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 1997-10-27 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2013-01-30 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2012-12-17 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2012-12-18 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 1989-09-08 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 2013-01-08 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1996-05-29 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1989-09-08 |
| Condenser, Amalgam And Foil, Operative | EKG | Class 1 | Dental | No | 1989-09-08 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 1996-05-29 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 1989-09-08 |
| Knife, Margin Finishing, Operative | EJZ | Class 1 | Dental | No | 2013-01-31 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 1989-09-08 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 1989-09-08 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1992-09-29 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 1997-06-19 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 1988-12-27 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 1989-09-08 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2013-01-08 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 1989-09-08 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 1989-09-08 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2013-01-31 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 1989-09-08 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2001-08-02 |
| File, Periodontic | EMR | Class 1 | Dental | No | 1997-10-27 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 1992-09-29 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 1996-05-29 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2012-12-17 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2014-07-21 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2002-02-05 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 1996-05-29 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2012-12-18 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 1989-09-08 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 1989-09-08 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 1982-02-15 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 2012-12-18 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 1996-05-29 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2012-12-18 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2013-01-08 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 1989-09-08 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2000-06-05 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 1997-06-19 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2013-01-30 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 1989-09-08 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 1996-05-29 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 1996-05-29 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 1988-12-27 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2013-01-30 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 1997-10-27 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 1997-10-27 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2013-11-18 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device