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Disposable Surgical Gowns
EUDAMEDClass I (EU MDR)
Ref E1001Model simple、standard、reinforce
Identity
- Trade Name
- Disposable Surgical Gowns EUDAMED
- Device Name
- Disposable Surgical Gowns EUDAMED
- Model / Reference
- simple、standard、reinforce EUDAMEDE1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 69742741610010 EUDAMED
- Basic UDI-DI
- 697427416DSGownsKE EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I 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 Gowns by Anhui Monique Medical 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 | 697427416DSGownsKE | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Monique Medical Materials Co., Ltd.
- EUDAMED SRN
- CN-MF-000001162
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 87e97a89-34b8-4a71-ab71-8dcaab481f0c 61 fields · synced Jul 17, 2026