FDA Registration
Active
🇩🇪 Germany
HANS HEPP GMBH & CO. KG
Reg #: 3003364331
·
FEI: 3003364331
·
Expires 2026
Products
9
Proprietary Names
13
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- HANS HEPP GMBH & CO. KG
- Registration Number
- 3003364331
- FEI Number
- 3003364331
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GEORGSWERDER DAMM 16
- City
- HAMBURG Lower Saxony
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K170575
Owner / Operator
- Firm Name
- HANS HEPP GMBH & CO. KG
- Operator Number
- 9027829
- Address
- GEORGSWERDER DAMM 16, --
- City
- HAMBURG D-20539
- State
- DE-NOTA
- Postal Code
- --
- Country
- DE
US Agent
- Business Name
- REGULATORY INSIGHT, INC.
- Contact Name
- KEVIN WALLS
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2023-07-31 |
| Sheet, Burn | FPY | Class 1 | General Hospital | No | 2023-07-11 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-07-11 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2023-07-11 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | QKR | Class N | Unknown | No | 2023-07-11 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2008-10-25 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2023-07-11 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2023-07-11 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2023-07-11 |
Proprietary Names
Disposable Gloves Size L
600mm x 800mm bandaging cloth A
plaster assortment
compress 8cm x 10cm first aid dressing M
compress 6cm x 8cm first aid dressing K
compress 10cm x 12cm first aid dressing G
Patient Examination Gloves
ca. 17,5cm x 9,5cm medical face mask
first aid kit
100mm x 100mm wound compresses
96cm x 96cm x 136cm triangular bandages
8cm x 4m elastic bandage
6cm x 4m elastic bandage
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device