FDA Registration
Active
🇳🇱 Netherlands
Surgical Drape Kit
Reg #: 3006540014
·
FEI: 3006540014
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- NOBEL BIOCARE DISTRIBUTION CENTER BV
- Registration Number
- 3006540014
- FEI Number
- 3006540014
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Popeweg 72
- City
- Venlo Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K110724
Owner / Operator
- Firm Name
- Nobel Biocare Services AG
- Operator Number
- 8030879
- Address
- Balz-Zimmermann-Strasse 7
- City
- Kloten
- State
- Zurich
- Postal Code
- 8302
- Country
- CH
- Correspondent
- Valeria Barbarito
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2021-09-16 |
| Drape, Surgical | KKX | Class 2 | General, Plastic Surgery | No | 2021-09-16 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2021-09-16 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2021-09-16 |
Proprietary Names
Surgical Drape Kit
Establishment Types
Export Device to the United States But Perform No Other Operation on Device