Identity
- Trade Name
- U6R CBT DB/UL 2245 ANDR HK CAP 5/-9/10 EUDAMED
- Device Name
- U6R CBT DB/UL 2245 ANDR HK CAP 5/-9/10 EUDAMED
- Model / Reference
- 438-0037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889989046885 EUDAMED
- Basic UDI-DI
- B-00889989046885 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
U6r Cbt Db/Ul 2245 Andr Hk Cap 5/-9/10 by Ormco Corporation — 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-00889989046885 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ormco Corporation
- EUDAMED SRN
- US-MF-000038085
- Authorised Representative
- KERR ITALIA SRL IT-AR-000007600
Sources (1)
- EUDAMED 29dec9cd-15e1-4f4d-bf6f-58410aaeee4e 61 fields · synced Jun 19, 2026