Identity
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974837949983 EUDAMED
- Basic UDI-DI
- 69748379401Q01593 EUDAMED
- EMDN Code
- T020603 MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) EUDAMED
Classification
- Device Class
- Class I 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
Medical Face Mask by PureMED Product (Yangzhou) 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 | 69748379401Q01593 | Class I | Active |
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Manufacturer
- Manufacturer
- PureMED Product (Yangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000013490
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 75c408d2-53f5-4015-9927-784cc2c4f96a 61 fields · synced Jul 8, 2026