Identity
- Trade Name
- D80 dermatome set FDA UDI
- Generic Name
- Dermatome handpiece, electrically-powered FDA UDI
- Device Name
- D80 dermatome set EUDAMED
- Model / Reference
- 4.D80STS EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 4.D80STS FDA UDI
- Primary DI / UDI-DI
- 08717903490365 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717903490365 EUDAMED
- FDA Product Code
- GFD FDA UDI
- EMDN Code
- L0103 DERMOTOMES AND BLADES, REUSABLE EUDAMED
- GMDN Term
- Dermatome handpiece, electrically-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
MR Conditional FDA UDI
D80 dermatome set by Humeca B.V. — Class IIa — 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-08717903490365 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Humeca B.V.
- EUDAMED SRN
- NL-MF-000010933
Sources (2)
- EUDAMED b5843849-dbdc-4763-a1f8-a0581d8e7c6a 61 fields · synced Aug 3, 2026
- FDA UDI dbf377b0-da8b-4a1e-aaf6-05ac6a2103f8 34 fields · synced May 30, 2026