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Ormco Digital Bonding Kit - DQ2 (double arch)
EUDAMEDClass IIa (EU MDR)
Ref 728-3104Model 728-310*
Identity
- Trade Name
- Ormco Digital Bonding Kit - DQ2 (double arch) EUDAMED
- Device Name
- Ormco Digital Bonding Kit EUDAMED
- Model / Reference
- 728-310* EUDAMED728-3104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889989088434 EUDAMED
- Basic UDI-DI
- 0889989-ODB_Metal_Bkts-MA 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
Category: Orthodontic tube
Ormco Digital Bonding Kit - DQ2 (double arch) by Ormco Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0889989-ODB_Metal_Bkts-MA | 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 2a95a8cc-2bdb-4754-8c41-58983869f958 61 fields · synced Jun 19, 2026