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Dental Impression Material
EUDAMEDClass I (EU MDR)
Ref GS-LHBModel GS-010YMN、Y60、GS-LHB、GS-HB、GS-LBRef GS-HBRef GS-010YMN
Identity
- Device Name
- Dental Impression Material EUDAMED
- Model / Reference
- GS-010YMN、Y60、GS-LHB、GS-HB、GS-LB EUDAMEDGS-LHB EUDAMEDGS-HB EUDAMEDGS-010YMN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970016620308 EUDAMED06970016620315 EUDAMED06970016620285 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 (3)
- EUDAMED 2bad795e-f2cd-48e5-9a5e-b5f14bcdd6e8 61 fields · synced Jul 22, 2026
- EUDAMED 5c6d1c0c-25cd-40dc-ad3e-d146b4653d66 61 fields · synced May 17, 2026
- EUDAMED 8531ba71-7f56-49eb-b32a-6a77b6213681 61 fields · synced May 17, 2026