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DAMON CUNITI .014 x .025 ARCHWIRE WITH ULTIMA HOOKS 5PK
EUDAMEDClass IIa (EU MDR)
Ref 227-0141Model 227-0*
Identity
- Trade Name
- DAMON CUNITI .014 x .025 ARCHWIRE WITH ULTIMA HOOKS 5PK EUDAMED
- Device Name
- DAMON ULTIMA ARCHWIRE WITH ULTIMA HOOK EUDAMED
- Model / Reference
- 227-0* EUDAMED227-0141 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889989088366 EUDAMED
- Basic UDI-DI
- 0889989-Wire_DUlt_ULhk-KP EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES 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
DAMON CUNITI .014 x .025 ARCHWIRE WITH ULTIMA HOOKS 5PK by Ormco Corporation — Class IIa — 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 | 0889989-Wire_DUlt_ULhk-KP | 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 b5164aa9-5921-433c-b88f-8e6118936399 61 fields · synced Aug 1, 2026