Identity
- Trade Name
- Scalpel Handle EUDAMED
- Device Name
- SCALPEL HANDLE # 3 EUDAMED
- Model / Reference
- C1 200 03 EUDAMEDC1 200 04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961102700422 EUDAMED08961102700439 EUDAMED
- Basic UDI-DI
- 896110270ZI0707SH900305M EUDAMED
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 by Ziana Industries — 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 | 896110270ZI0707SH900305M | Class I | Active |
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Manufacturer
- Manufacturer
- Ziana Industries
- EUDAMED SRN
- PK-MF-000011900
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (2)
- EUDAMED c6d830dc-8992-4560-bb5b-ed039daf49f4 61 fields · synced Sep 18, 2026
- EUDAMED dae46b69-344a-43d4-a9f8-71b7b139170e 61 fields · synced May 18, 2026