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Ok Real Resin Bracket
EUDAMEDClass IIa (EU MDR)
Ref 640-053Model 640-053 OK BRACKET STD 018
Identity
- Trade Name
- OK REAL RESIN BRACKET EUDAMED
- Model / Reference
- 640-053 OK BRACKET STD 018 EUDAMED640-053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033403876 EUDAMED
- Basic UDI-DI
- B-08800033403876 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
Ok Real Resin Bracket by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08800033403876 | 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 ebf6bda5-faed-4cd4-b91d-7babe38571ea 61 fields · synced Jun 19, 2026