FDA Registration
Active
🇩🇪 Germany
Denzel Medical GmbH & Co. KG
Reg #: 8043441
·
FEI: 3007714917
·
Expires 2026
Products
33
Proprietary Names
0
Establishment Types
1
Classifications
33
Registration Details
- Registration Name
- Denzel Medical GmbH & Co. KG
- Registration Number
- 8043441
- FEI Number
- 3007714917
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- TAKE-OFF GEWERBEPARK 65
- City
- NEUHAUSEN Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- Denzel Medical GmbH & Co. KG
- Operator Number
- 9001458
- Address
- TAKE-OFF GEWERBEPARK 65, --
- City
- NEUHAUSEN
- State
- Baden-Wurttemberg
- Postal Code
- 78579
- Country
- DE
- Correspondent
- LOTHAR - DENZEL
US Agent
- Business Name
- Business Support International
- Contact Name
- Angelika Scherp
- Address
- 1350 Avenue Of The Americas Floor 2NDNEW
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 212 3318358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2005-03-28 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2012-12-18 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1990-10-16 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-03-25 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2021-04-12 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 2018-11-19 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2003-08-13 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2004-09-16 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2013-12-18 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2024-04-18 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2017-11-15 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2016-02-19 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2024-04-18 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2004-09-16 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2025-02-07 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2012-12-18 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2015-10-12 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2025-04-29 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2021-03-25 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2020-11-23 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2004-09-16 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2003-08-13 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2013-05-15 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 2016-10-17 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1990-10-16 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2003-10-17 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2015-10-12 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2016-10-26 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2022-12-01 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2015-10-22 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2004-09-16 |
| Keratoscope, Battery-Powered | HLR | Class 1 | Ophthalmic | No | 2014-03-19 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2015-10-12 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)