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Humeca blade for Padgett® (B +3 more) - S dermatome
EUDAMEDClass IIa (EU MDR)
Ref 5.BLPG10
by Humeca B.V.
Identity
- Device Name
- Humeca blade for Padgett® model B, C and S dermatome, 10pcs EUDAMED
- Model / Reference
- 5.BLPG10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717903495414 EUDAMED
- Basic UDI-DI
- B-08717903495414 EUDAMED
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
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 blade for Padgett® (B +3 more) - S dermatome by Humeca B.V. — Class IIa — MDD — listed in EUDAMED — 4 models — regulatory data on deviCERTS
Similar devices
Also classified as Manual scalpel blade, single-use.
- Paramount — Paramount Surgimed Limited · Class IIa
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- Swann-Morton — Swann-Morton Ltd · Class IIa
- SHARD — APPLIED DENTAL, INC. · Class I
- Sterile Stainless Blades — Southmedic Incorporated · Class I
- Paramount — Paramount Surgimed Limited · Class IIa
- Swann-Morton — Swann-Morton Ltd · Class IIa
- 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-08717903495414 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Humeca B.V.
- EUDAMED SRN
- NL-MF-000010933
Sources (1)
- EUDAMED b59c002f-bad1-43ca-b0a9-59bce11d84db 61 fields · synced Oct 5, 2026