FDA Registration
Active
🇳🇱 Netherlands
6.V10-3PS V-Carr. 1:3 Humeca and Zimmer mesher 5 per
Reg #: 3008950755
·
FEI: 3008950755
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HUMECA BV
- Registration Number
- 3008950755
- FEI Number
- 3008950755
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Oostermaat 5
- City
- Borne Overijssel
- Country
- NL
Owner / Operator
- Firm Name
- Humeca BV
- Operator Number
- 10035227
- Address
- Oostermaat 5
- City
- Borne
- State
- NL-NOTA
- Postal Code
- 7623 CS
- Country
- NL
- Correspondent
- Johannes A Van Velzen
US Agent
- Business Name
- QSR Consulting
- Contact Name
- Kenneth Kleinhenz
- Address
- 4141 Elm Rd.
- City
- Hudson
- State
- MI
- ZIP
- 49247
- Country
- US
- [email protected]
- Phone
- 619 2449573
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2011-02-14 |
Proprietary Names
6.V10-3PS V-Carr. 1:3 Humeca and Zimmer mesher 5 per
6,204 Circular blade, Ø 36 mm for Humeca mesher
6.V10.1 PS V carr. !:1 Humeca and Zimmer mesher 5 carriers
6.V5-1 PS V-carr. 1:1 Humeca and Zimmer mesher
6.v10-2PS V-carr. 1:2 Humeca and Zimmer mesher 5 per
6.HMAC02 Autoclave case for the cutting axis of the Humeca®
6.HM01 Humeca® mesher
Humeca® mesher
6.HMAC01 Autoclave case for Humeca® mesher
6.KN50/36 Cutting axis, containing 50 blades Ø 36 mm
6.V10-1.5PS V-Carr 1-1.5 Humeca and Zimmer mesher 5 per
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device