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Shouren
EUDAMEDClass I (EU MDR)
Ref 0224Model 17.5cm×9.5cm;14.5cm×9.5cm;12.5cm×9.5cm
Identity
- Trade Name
- Shouren EUDAMED
- Device Name
- Medical surgical mask EUDAMED
- Model / Reference
- 17.5cm×9.5cm;14.5cm×9.5cm;12.5cm×9.5cm EUDAMED0224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973091700224 EUDAMED
- Basic UDI-DI
- 69730917010017P EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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 | 69730917010017P | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000034396
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 8801ad5d-5c2e-4346-b447-0210c71dcdab 61 fields · synced Jun 19, 2026