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Dental Impression Material
EUDAMEDClass I (EU MDR)
Ref Y60Model GS-010YMN、Y60、GS-LHB、GS-HB、GS-LB
Identity
- Device Name
- Dental Impression Material EUDAMED
- Model / Reference
- GS-010YMN、Y60、GS-LHB、GS-HB、GS-LB EUDAMEDY60 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970016620292 EUDAMED
- Basic UDI-DI
- 697001662DImpressionYD EUDAMED
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Dental Impression Material by Jiangxi Dentalbright Technology Co., Ltd — 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 | 697001662DImpressionYD | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangxi Dentalbright Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000009767
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 14597569-4b77-463a-a5d5-38281cf605fa 61 fields · synced Jun 18, 2026