Identity
- Trade Name
- Sterile Surgical Gowns EUDAMED
- Device Name
- Sterile Surgical Gowns EUDAMED
- Model / Reference
- XL 140x138cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970542773899 EUDAMED
- Basic UDI-DI
- 697054277102-SGUC EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
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
Sterile Surgical Gowns 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 | 697054277102-SGUC | 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 8c6eba73-8124-4e48-b034-6b4c06f84eed 61 fields · synced Jun 19, 2026