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Humeca D80 Dermatome blade, 10pcs
EUDAMEDClass IIa (EU MDR)
Ref 5.D80BL10Ref 4.D80
by Humeca B.V.
Identity
- Device Name
- Humeca D80 Dermatome blade, 10pcs EUDAMEDD80 dermatome EUDAMED
- Model / Reference
- 5.D80BL10 EUDAMED4.D80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717903495803 EUDAMED08717903490419 EUDAMED
- Basic UDI-DI
- B-08717903495803 EUDAMEDB-08717903490419 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMEDL0103 DERMOTOMES AND BLADES, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Manual scalpel blade, single-use
Humeca D80 Dermatome blade, 10pcs by Humeca B.V. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Manual scalpel blade, single-use.
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- SHARD — APPLIED DENTAL, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08717903495803 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Humeca B.V.
- EUDAMED SRN
- NL-MF-000010933
Sources (2)
- EUDAMED bf4e8d62-1d94-4606-abe7-81dff72f9f33 61 fields · synced Jun 20, 2026
- EUDAMED ada8056c-5eba-443d-b9bf-4f0580245bfa 61 fields · synced May 18, 2026