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iGOS Low Flow A4 2.6 g (1.5 ml)
EUDAMEDClass IIa (EU MDR)
Ref iGOSModel Dental Resin
Identity
- Trade Name
- iGOS Low Flow A4 2.6 g (1.5 ml) EUDAMED
- Device Name
- iGOS EUDAMED
- Model / Reference
- Dental Resin EUDAMEDiGOS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560231204265 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
Category: Dental composite resin
iGOS Low Flow A4 2.6 g (1.5 ml) by Yamakin Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
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 0157238b-d7de-40c7-8c8c-5178539eb5ae 61 fields · synced Jul 14, 2026