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Ok Real Resin Bracket
EUDAMEDClass IIa (EU MDR)
Ref 640-503Model 640-503 OK BRACKET STD 018
Identity
- Trade Name
- OK REAL RESIN BRACKET EUDAMED
- Model / Reference
- 640-503 OK BRACKET STD 018 EUDAMED640-503 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033403906 EUDAMED
- Basic UDI-DI
- B-08800033403906 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Orthodontic tube
Ok Real Resin Bracket by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800033403906 | Class IIa | 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 449d2b37-a500-45d6-a8eb-a33d34741aa4 61 fields · synced Jun 18, 2026