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Shouren
EUDAMEDClass I (EU MDR)
Ref 0040Model STANDARD S、STANDARD M、STANDARD L、STANDARD XL、STANDARD XXL、STANDARD XXXL;
Identity
- Trade Name
- Shouren EUDAMED
- Device Name
- Surgical gown EUDAMED
- Model / Reference
- STANDARD S、STANDARD M、STANDARD L、STANDARD XL、STANDARD XXL、STANDARD XXXL; EUDAMED0040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973091700040 EUDAMED
- Basic UDI-DI
- 69730917010027R 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
Shouren by Shaoxing Shouren Medical Health & Technology 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 | 69730917010027R | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000034396
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED b438a5e9-4695-4c52-9d8c-025bc048a2dc 61 fields · synced Oct 6, 2026