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Face mask
EUDAMEDClass I (EU MDR)
Ref 1A3100Model 1A3100 1A3101 1A3102 1A3103 1A3104 1A3130 1A3131 1A3132 1A3133 1A3134 1A3150 1A3152 1A3314 1A3310 1A3300 1A3314
Identity
- Trade Name
- Face mask EUDAMED
- Device Name
- Face Mask EUDAMED
- Model / Reference
- 1A3100 1A3101 1A3102 1A3103 1A3104 1A3130 1A3131 1A3132 1A3133 1A3134 1A3150 1A3152 1A3314 1A3310 1A3300 1A3314 EUDAMED1A3100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977493109821 EUDAMED
- Basic UDI-DI
- 697749310010019VH EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Face mask by Shanghai Dochem Industries 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 | 697749310010019VH | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Dochem Industries Co., Ltd.
- EUDAMED SRN
- CN-MF-000014350
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED abebb0be-a33f-4b90-918c-ebbc017f8925 61 fields · synced Jul 21, 2026