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MEEK set machine driven complete
EUDAMEDFDA UDIClass I (EU MDR)
Ref 3.MD
by Humeca B.V.
Identity
- Trade Name
- MEEK set machine driven complete FDA UDI
- Generic Name
- Skin graft mesher FDA UDI
- Device Name
- MEEK set machine driven complete EUDAMED
- Model / Reference
- 3.MD EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 3.MD FDA UDI
- Primary DI / UDI-DI
- 08717903490396 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717903490396 EUDAMED
- FDA Product Code
- GFD 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
- 878.4820 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
MEEK set machine driven complete 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-08717903490396 | 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 1ab8a5ab-b764-4c58-b9c8-39a195535b0d 61 fields · synced Jul 9, 2026
- FDA UDI 32f10c67-093c-4171-ac1f-affa5709a908 33 fields · synced May 30, 2026