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Examination Gown
EUDAMEDClass I (EU MDR)
Ref 3821Ref 3820Model XS,S,M,L,XL,XXL,XXXL,XXXXL
Identity
- Trade Name
- Examination Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- 3821 EUDAMED3820 EUDAMEDXS,S,M,L,XL,XXL,XXXL,XXXXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16973210340451 EUDAMED16973210340444 EUDAMED06973210343073 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 (4)
- EUDAMED ca28e49f-305b-4409-979b-5ed2fe7722da 61 fields · synced Aug 3, 2026
- EUDAMED c0f641c7-284e-415e-a3a9-0067d8bacc21 61 fields · synced May 18, 2026
- EUDAMED b1b4a87f-3913-4763-884c-0bde5b0923f3 61 fields · synced Aug 1, 2026
- EUDAMED 1986a502-9e66-4156-87f8-a3370cf7668a 61 fields · synced Aug 3, 2026