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BK MASK ivory(blue, violet)
EUDAMEDClass I (EU MDR)
Ref 801-76Model FACE MASK/ BK MASK
Identity
- Trade Name
- BK MASK ivory(blue, violet) EUDAMED
- Model / Reference
- FACE MASK/ BK MASK EUDAMED801-76 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033438892 EUDAMED
- Basic UDI-DI
- 8800033401207V EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
BK MASK ivory(blue, violet) by Osstem Orthodontics Inc. — 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 | 8800033401207V | Class I | Active |
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Manufacturer
- Manufacturer
- Osstem Orthodontics Inc.
- EUDAMED SRN
- KR-MF-000021559
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED f98e1194-fcd3-447a-9365-90ac7a1eaa06 61 fields · synced Jul 20, 2026