Identity
- Trade Name
- Isolation Gowns EUDAMED
- Device Name
- Isolation Gowns EUDAMED
- Model / Reference
- XL EUDAMEDS EUDAMEDM EUDAMEDXXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06932523030964 EUDAMED06932523030933 EUDAMED06932523030940 EUDAMED06932523030971 EUDAMED
- Basic UDI-DI
- 697170524Gowns01WV EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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 JiangSu MedPlus Non-Woven Manufacturer 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 | 697170524Gowns01WV | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Medplus Non-woven Manufacturer Co., Ltd.
- EUDAMED SRN
- CN-MF-000022548
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (4)
- EUDAMED df8817f9-f730-4def-98b3-2f959baa8117 61 fields · synced Oct 6, 2026
- EUDAMED 861548f6-3f82-47bc-8bff-85baa899c64e 61 fields · synced May 17, 2026
- EUDAMED 261d9c1e-062c-491d-a319-3e0791acd037 61 fields · synced May 18, 2026
- EUDAMED 7484faa2-0c74-400d-aa9b-926b99c4dc9c 61 fields · synced May 18, 2026