Identity
- Trade Name
- Cévka pupeční pro novorozence CP-01 M EUDAMED
- Device Name
- Cévka pupeční pro novorozence EUDAMED
- Model / Reference
- V646958-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08593540514943 EUDAMED
- Basic UDI-DI
- 85935406TF23NOVOROZENCPH3 EUDAMED
- EMDN Code
- V028002 NEONATOLOGY CARE KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cévka pupeční pro novorozence CP-01 M by GAMA GROUP a.s. — 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 | 85935406TF23NOVOROZENCPH3 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GAMA GROUP a.s.
- EUDAMED SRN
- CZ-MF-000011894
Sources (1)
- EUDAMED 89a2698c-7234-4bb7-8845-c0b121ae991b 61 fields · synced Jul 12, 2026