Identity
- Device Name
- Surgical Gowns EUDAMED
- Model / Reference
- E-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974633370028 EUDAMED
- Basic UDI-DI
- 697463337E-BQ3 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Surgical Gowns by Sichuan Shuzhan New Materials 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 | 697463337E-BQ3 | Class I | Active |
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Manufacturer
- Manufacturer
- Sichuan Shuzhan New Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000010104
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED c3bbe848-bf25-476a-b4f5-52f06323ee24 61 fields · synced Jul 9, 2026