FDA Registration
Active
🇺🇸 United States
6.V10-3PS V-Carr. 1:3 Humeca and Zimmer mesher 5 per
Reg #: 3012366928
·
FEI: 3012366928
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Humeca, Inc.
- Registration Number
- 3012366928
- FEI Number
- 3012366928
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 9822 NE 2nd Ave Suite 7
- City
- Miami Shores
- State
- FL
- ZIP
- 33138
- Country
- US
Owner / Operator
- Firm Name
- Humeca BV
- Operator Number
- 10035227
- Address
- Oostermaat 5
- City
- Borne
- State
- NL-NOTA
- Postal Code
- 7623 CS
- Country
- NL
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
Complaint File Establishment per 21 CFR 820.198