Identity
- Trade Name
- Surgical mask EUDAMED
- Device Name
- Medical face mask EUDAMED
- Model / Reference
- HXM-05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26974181710677 EUDAMED
- Basic UDI-DI
- 697418171HXM05LQ EUDAMED
- Direct Marketing DI
- 26974181710677 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
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
Surgical mask by Xianning Huaxin Garment 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 | 697418171HXM05LQ | Class I | Active |
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Manufacturer
- Manufacturer
- Xianning Huaxin Garment Co., Ltd
- EUDAMED SRN
- CN-MF-000008984
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 70c04291-f8b0-401d-9b47-5c853b3de15d 61 fields · synced Jun 17, 2026