Identity
- Device Name
- Isolation Gowns EUDAMED
- Model / Reference
- CD19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391525841021 EUDAMED
- Basic UDI-DI
- 53915258354924Z EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) 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
Isolation Gowns by Fannin 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 | 53915258354924Z | Class I | Active |
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Manufacturer
- Manufacturer
- Fannin Ltd.
- EUDAMED SRN
- IE-MF-000002373
Sources (1)
- EUDAMED 55b42144-7193-4c38-90e4-f2cda56701e7 61 fields · synced Jul 18, 2026