Identity
- Trade Name
- PathAguard Safesheet EUDAMED
- Device Name
- PathAguard Safesheet EUDAMED
- Model / Reference
- CMCSS10001A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391528050147 EUDAMED
- Basic UDI-DI
- 539152805013CK EUDAMED
- EMDN Code
- V80 CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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 Safesheet by Cmc Hygea Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: PathAguard Safesheet
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 | 539152805013CK | Class I | Active |
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Manufacturer
- Manufacturer
- Cmc Hygea Ltd
- EUDAMED SRN
- IE-MF-000005163
Sources (1)
- EUDAMED 90d11795-6fb4-4fef-abe3-bdb57a1ee77d 61 fields · synced Jul 31, 2026