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Safewear Pp+pe 30g/M² Waterproof Isolation Gown
EUDAMEDClass I (EU MDR)
Ref 40.421
Identity
- Trade Name
- SAFEWEAR PP+PE 30G/M² WATERPROOF ISOLATION GOWN EUDAMED
- Device Name
- isolation gown EUDAMED
- Model / Reference
- 40.421 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973122516985 EUDAMED
- Basic UDI-DI
- 697312251IG10073 EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Safewear Pp+pe 30g/M² Waterproof Isolation Gown by Crown Name Disposable Hygiene Products Fty. Ltd. — Class I — MDR — listed in EUDAMED
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 | 697312251IG10073 | Class I | Active |
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Manufacturer
- Manufacturer
- Crown Name Disposable Hygiene Products Fty. Ltd.
- EUDAMED SRN
- CN-MF-000008238
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 206a1c52-bd32-4e52-89b3-9a9c21eef0a7 61 fields · synced Jun 19, 2026