Identity
- Trade Name
- SCALPEL HANDLE N°4 EUDAMED
- Device Name
- SCALPEL HANDLE N°4 EUDAMED
- Model / Reference
- MBIST4.1 / 745-040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89640040173912 EUDAMED
- Basic UDI-DI
- 8964004017MBIST4.1XV EUDAMED
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Scalpel Handle N°4 by Metech International — Class I — 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 | 8964004017MBIST4.1XV | Class I | Active |
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Manufacturer
- Manufacturer
- Metech International
- EUDAMED SRN
- PK-MF-000041396
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED bcaaa201-2a48-4fd8-909b-b7a090f57f29 61 fields · synced Aug 2, 2026