Identity
- Trade Name
- G4™ TAD EUDAMED
- Device Name
- Orthodontic NiTi Springs EUDAMED
- Model / Reference
- CCOT12HV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190886108482 EUDAMED
- Basic UDI-DI
- 0190886NiTiSpringsPV EUDAMED
- Unit of Use DI
- 00190886108485 EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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 retainer
G4™ Tad by G&H Wire Company, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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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 | 0190886NiTiSpringsPV | Class IIa | Active |
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Manufacturer
- Manufacturer
- G&H Wire Company, Inc.
- EUDAMED SRN
- US-MF-000012129
- Authorised Representative
- G&H Europe BV NL-AR-000022839
Sources (1)
- EUDAMED da8ae207-4b26-4db0-aa83-0d8bdabc4b93 61 fields · synced Jul 11, 2026