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Humeca blade for Padgett® (B +2 more) - B
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5.BLPG/1
by Humeca B.V.
Identity
- Trade Name
- Humeca blade for Padgett® model B, C and S dermatome FDA UDI
- Generic Name
- Dermatome blade, single-use FDA UDI
- Device Name
- Humeca blade for Padgett® model B, C and S dermatome EUDAMED
- Model / Reference
- 5.BLPG/1 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 5.BLPG/1 FDA UDI
- Primary DI / UDI-DI
- 08717903490181 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717903490181 EUDAMED
- FDA Product Code
- GFD FDA UDI
- EMDN Code
- V010302 BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Dermatome blade, single-use FDA UDI
- Models / Variants
- B EUDAMEDFDA 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual scalpel blade, single-use
Humeca blade for Padgett® (B +2 more) - B by Humeca B.V. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models — 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 (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-08717903490181 | 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 24a397ad-8b76-4142-a00f-bbac8ec22623 61 fields · synced Jun 18, 2026
- FDA UDI cec6d908-0f94-43d4-81ee-9ace4fd6a717 33 fields · synced May 27, 2026