Identity
- Trade Name
- Füllinstrument gebogen 1,5mm EUDAMED
- Device Name
- Füllinstrument gebogen 1,5mm EUDAMED
- Model / Reference
- FITH-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- G375FITHC EUDAMED
- Basic UDI-DI
- ++G375FITHC6H EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Latvia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Füllinstrument gebogen 1, 5mm by Immane Corporation — Class I — 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 | ++G375FITHC6H | Class I | Active |
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Manufacturer
- Manufacturer
- Immane Corporation
- EUDAMED SRN
- PK-MF-000035233
- Authorised Representative
- CS Active LV-AR-000011602
Sources (1)
- EUDAMED 60626405-8c3a-445a-9ad3-6bacf484416c 61 fields · synced Jun 19, 2026