Identity
- Trade Name
- NEOGRAFT 2.0 EUDAMEDNeograft FDA UDI
- Generic Name
- Hair extraction punch FDA UDI
- Device Name
- NEOGRAFT EUDAMED
- Model / Reference
- MED011 EUDAMED2.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701330200005 EUDAMEDFDA UDI
- Basic UDI-DI
- 137013302MED011KP1XXSQ EUDAMED
- FDA Product Code
- GEY FDA UDI
- EMDN Code
- K0199 ENDOTHERAPY DEVICES - OTHER EUDAMED
- GMDN Term
- Hair extraction punch FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- France 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Neograft 2.0 by Electronique Du Mazet — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 137013302MED011KP1XXSQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Electronique Du Mazet
- EUDAMED SRN
- FR-MF-000001805
Sources (2)
- EUDAMED 300e14f8-8fea-44b7-978b-7e0f70a02b0f 61 fields · synced Aug 4, 2026
- FDA UDI 50d58562-22b3-46e1-a93f-255271165e6e 33 fields · synced May 30, 2026