Identity
- Trade Name
- Surgical Mask EUDAMED
- Device Name
- Surgical Mask EUDAMED
- Model / Reference
- 175mm×95mm、140mm×95mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973131521017 EUDAMED
- Basic UDI-DI
- 697313152BKDSFMEN EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Surgical Mask by Biobase Scientific (Shandong)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 | 697313152BKDSFMEN | Class I | Active |
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Manufacturer
- Manufacturer
- Biobase Scientific (Shandong) Co., Ltd
- EUDAMED SRN
- CN-MF-000011660
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3ce7df80-825c-4805-b791-b8254532fae2 61 fields · synced Jul 12, 2026