Identity
- Trade Name
- FACEMASK BL_Org EUDAMED
- Model / Reference
- FACE MASK/ BK MASK EUDAMED801-71 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033438939 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
FACEMASK BL_Org 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 c9cb511d-760c-4051-9831-9799e5b3c5d0 61 fields · synced Jun 18, 2026