Identity
- Trade Name
- PathAguard LUCA EUDAMEDPathAguard LUCA Dispenser EUDAMED
- Device Name
- PathAguard LUCA EUDAMEDPathAguard LUCA Dispenser EUDAMED
- Model / Reference
- CMCU10001A EUDAMEDCMCD10002A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391528050093 EUDAMED05391528050048 EUDAMED
- Basic UDI-DI
- 539152805009CU EUDAMED539152805004CJ EUDAMED
- EMDN Code
- Y093399 WASHING, BATHING AND SHOWERING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
PathAguard LUCA by Cmc Hygea Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: PathAguard LUCA
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 | 539152805009CU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cmc Hygea Ltd
- EUDAMED SRN
- IE-MF-000005163
Sources (2)
- EUDAMED ff5e8a70-e672-4f8e-9921-999e65c68e9c 61 fields · synced Jul 12, 2026
- EUDAMED 5c6b603e-3c99-4f64-b70c-36ff49666a41 61 fields · synced May 18, 2026