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Humeca blade for Humby long knife (20cm/7.9 in), 10pcs
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 5.BLHUL10Ref 5.BLHUL/1
by Humeca B.V.
Identity
- Trade Name
- Humeca blade for Humby long knife (20cm/7.9 in) FDA UDI
- Generic Name
- Dermatome blade, single-use FDA UDI
- Device Name
- Humeca blade for Humby long knife (20cm/7.9 in), 10pcs EUDAMEDHumeca blade for Humby long knife (20cm/7.9 in) EUDAMED
- Model / Reference
- 5.BLHUL10 EUDAMED5.BLHUL/1 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 5.BLHUL/1 FDA UDI
- Primary DI / UDI-DI
- 08717903490273 EUDAMED08717903490242 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08717903490273 EUDAMEDB-08717903490242 EUDAMED
- FDA Product Code
- GES 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
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 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 Humby long knife (20cm/7.9 in), 10pcs by Humeca B.V. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Manual scalpel blade, single-use.
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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-08717903490273 | 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 (3)
- EUDAMED a73e9e8a-4bcc-4f0b-92d8-196a26595e87 61 fields · synced Jul 9, 2026
- EUDAMED 1e4d2da8-da17-4959-8916-ac10e2dbb257 61 fields · synced May 17, 2026
- FDA UDI 49d49ae1-9a3d-4f2c-8532-890bd525b58c 33 fields · synced May 30, 2026