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Medical Face Mask
EUDAMEDClass I (EU MDR)
Ref 4148 17.5×9.5Model Type IRef 4148 17.5×9.5Model Type II/IIR
Identity
- Trade Name
- Medical Face Mask EUDAMED
- Device Name
- Medical Face Mask EUDAMEDMedical Face Mask EUDAMED
- Model / Reference
- Type I EUDAMED4148 17.5×9.5 EUDAMEDType II/IIR EUDAMED4148 17.5×9.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972968292497 EUDAMED06972968291278 EUDAMED
- Basic UDI-DI
- 697296829mask002EE EUDAMED697296829mask001EC EUDAMED
- EMDN Code
- T020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) EUDAMEDT020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Medical Face Mask by Anshi Medical Group 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 | 697296829mask002EE | Class I | Active |
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Manufacturer
- Manufacturer
- Anshi Medical Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000007263
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED ac086d68-365a-485e-a310-c3d709714bfe 61 fields · synced Jul 14, 2026
- EUDAMED d5e792e9-64d9-4440-bd61-7d14a07a1d58 61 fields · synced May 17, 2026