Identity
- Trade Name
- CMC HYGEA LTD EUDAMED
- Device Name
- Multipurpose Compostable System EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391528050215 EUDAMED
- Basic UDI-DI
- 539152805021CJ EUDAMED
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Cmc Hygea Ltd by Cmc Hygea Ltd — 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 | 539152805021CJ | Class I | Active |
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Manufacturer
- Manufacturer
- Cmc Hygea Ltd
- EUDAMED SRN
- IE-MF-000005163
Sources (1)
- EUDAMED 1d039d1b-a8d6-43c8-9b41-5c5e8f0d754a 61 fields · synced Jul 13, 2026