Identity
- Trade Name
- Isolation Gown EUDAMED
- Device Name
- Isolation Gown EUDAMED
- Model / Reference
- XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970542770614 EUDAMED
- Basic UDI-DI
- 697054277IGZF EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Suzhou Suning Underpad 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 | 697054277IGZF | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Suning Underpad Co., Ltd.
- EUDAMED SRN
- CN-MF-000020331
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 695c5349-b7b7-438c-b5bc-92766da6d5a9 61 fields · synced Jun 20, 2026