Identity
- Trade Name
- Surgical Blade EUDAMED
- Device Name
- Surgical Blade EUDAMED
- Model / Reference
- BLD EUDAMED
Identifiers
- Primary DI / UDI-DI
- BLD-10-1 EUDAMED
- Basic UDI-DI
- ++G401BLDQ4 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
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Surgical Blade by Disposafe Health & Lifecare Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G401BLDQ4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Disposafe Health & Lifecare Limited
- EUDAMED SRN
- IN-MF-000020265
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 22da758f-5043-4257-8b7d-865384163eab 61 fields · synced Jun 18, 2026