Identity
- Trade Name
- WIRE 7IN.0190 DEAD SOFT RESPOND PK10 EUDAMED
- Device Name
- WIRE 7IN.0190 DEAD SOFT RESPOND PK10 EUDAMED
- Model / Reference
- 264-1190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00889989033533 EUDAMED
- Basic UDI-DI
- B-00889989033533 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
Wire 7in.0190 Dead Soft Respond Pk10 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-00889989033533 | 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 d84d0563-1065-4fff-a87a-8e59296f574f 61 fields · synced Jul 29, 2026