Identity
- Device Name
- Disposable Surgical Gown EUDAMED
- Model / Reference
- Type Ⅰ1201S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972968291292 EUDAMED
- Basic UDI-DI
- 697296829gown050KA EUDAMED
- Direct Marketing DI
- 06972968291292 EUDAMED
- EMDN Code
- T020402 REINFORCED 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
Disposable Surgical Gown by Anshi Medical Group 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 | 697296829gown050KA | Class I | Active |
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Manufacturer
- Manufacturer
- Anshi Medical Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000007263
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED cca5c74c-239d-460d-9704-9e6a545561b5 61 fields · synced Jul 9, 2026