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Isolation Gown
EUDAMEDClass I (EU MDR)
Ref 1358Model XS,S,M,L,XL,XXL,XXXL,XXXXL Ref AM3037
Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- XS,S,M,L,XL,XXL,XXXL,XXXXL EUDAMED1358 EUDAMEDAM3037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16973210340406 EUDAMED06973210342298 EUDAMED
- Basic UDI-DI
- 697321034isolationgown4S EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMEDGermany 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 Gown by Aimmax Medical Products Co., 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 | 697321034isolationgown4S | Class I | Active |
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Manufacturer
- Manufacturer
- Aimmax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000010875
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED ba6285e7-04e9-44a2-96fa-99bfb160d82e 61 fields · synced Jul 8, 2026
- EUDAMED d95efacd-a90e-46b7-bd9f-033edb063006 61 fields · synced Jun 18, 2026