Identity
- Trade Name
- Scalpel EUDAMED
- Device Name
- Scalpel EUDAMED
- Model / Reference
- 06-140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G379061400 EUDAMED
- Basic UDI-DI
- ++G37906140LN EUDAMED
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
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
Scalpel by Pak K.t.s 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 | ++G37906140LN | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pak K.t.s International
- EUDAMED SRN
- PK-MF-000029944
- Authorised Representative
- CS Active LV-AR-000011602
Sources (1)
- EUDAMED 06e4ca16-05d9-4998-b4ca-fa15af4e1cb6 61 fields · synced Jul 25, 2026