← Back to catalogue
Shouren
EUDAMEDClass I (EU MDR)
Ref 100402Model 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; EUDAMED100402 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973091700026 EUDAMED
- Basic UDI-DI
- 69730917010027R EUDAMED
- EMDN Code
- T020402 REINFORCED 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 — CE/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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CN-MF-000034396
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 2fb94372-9f7e-4b21-b734-4ff4f0f7a5a9 61 fields · synced Oct 6, 2026