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Single-use medical surgical face mask
EUDAMEDClass I (EU MDR)
Ref ES17.5Model Model:Ear loop, Bandage Specifications：20×18cm, 17×17cm,17.5×9.5cm, 14.5×9.5cm,14.5×9cm, 12.5×9cm, 12×7cm
Identity
- Trade Name
- Single-use medical surgical face mask EUDAMED
- Device Name
- Single-use medical surgical face mask EUDAMED
- Model / Reference
- Model:Ear loop, Bandage Specifications：20×18cm, 17×17cm,17.5×9.5cm, 14.5×9.5cm,14.5×9cm, 12.5×9cm, 12×7cm EUDAMEDES17.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 66920756700404 EUDAMED
- Basic UDI-DI
- 69207567YYWKKZ00019N EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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
Single-use medical surgical face mask by Jiangxi Hongda Medical Equipment Group 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 | 69207567YYWKKZ00019N | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangxi Hongda Medical Equipment Group Ltd.
- EUDAMED SRN
- CN-MF-000006019
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 70e3e66f-1a92-461f-a956-0b2f0e38db68 61 fields · synced Jun 18, 2026