Identity
- Trade Name
- Humeca mesher FDA UDI
- Generic Name
- Skin graft mesher FDA UDI
- Device Name
- Humeca mesher EUDAMED
- Model / Reference
- 6.HM01 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 6.HM01 FDA UDI
- Primary DI / UDI-DI
- 08717903490372 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717903490372 EUDAMED
- FDA Product Code
- FZT FDA UDI
- EMDN Code
- L2499 DERMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Skin graft mesher FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Humeca mesher by Humeca B.V. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08717903490372 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Humeca B.V.
- EUDAMED SRN
- NL-MF-000010933
Sources (2)
- EUDAMED abd3ade1-9b08-4d65-aa9c-3068f70630de 61 fields · synced Jul 9, 2026
- FDA UDI e174f93d-0f23-4aa4-a23b-e3d62544f5e5 33 fields · synced May 30, 2026