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Examination Gown
EUDAMEDClass I (EU MDR)
Ref 3820Model XS,S,M,L,XL,XXL,XXXL,XXXXL
Identity
- Trade Name
- Examination Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- XS,S,M,L,XL,XXL,XXXL,XXXXL EUDAMED3820 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973210343066 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
- Sweden 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
Examination 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 (1)
- EUDAMED d33e8d16-5857-4706-8f03-4e6c75d078a7 61 fields · synced Jun 19, 2026