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iGOS Low Flow A3.5 2.6 g (1.5 ml)
EUDAMEDClass IIa (EU MDR)
Ref iGOSModel Dental Resin
Identity
- Trade Name
- iGOS Low Flow A3.5 2.6 g (1.5 ml) EUDAMED
- Device Name
- iGOS EUDAMED
- Model / Reference
- Dental Resin EUDAMEDiGOS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560231204258 EUDAMED
- Basic UDI-DI
- 456023117D10B102N001UT EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
iGOS Low Flow A3.5 2.6 g (1.5 ml) by Yamakin Co., Ltd. — 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 | 456023117D10B102N001UT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Yamakin Co., Ltd.
- EUDAMED SRN
- JP-MF-000011382
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 47a1d647-0767-416b-a7ca-600870fd4401 61 fields · synced Jun 19, 2026