Identity
- Trade Name
- Face mask type IIR EUDAMED
- Device Name
- Face mask TYPEIIR EUDAMED
- Model / Reference
- HXM-06 EUDAMED2024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974181710700 EUDAMED
- Basic UDI-DI
- 697418171HXM-06LR EUDAMED
- Direct Marketing DI
- 16974181710700 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Face mask type IIR 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 | 697418171HXM-06LR | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xianning Huaxin Garment Co., Ltd
- EUDAMED SRN
- CN-MF-000008984
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2e74a9c4-ec1f-4da3-b621-293a4ead8aec 61 fields · synced Jul 18, 2026