Identity
- Device Name
- Gingival Barrier EUDAMED
- Model / Reference
- GS-012G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970016620339 EUDAMED
- Basic UDI-DI
- 697001662GingivalL5 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER 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
Gingival Barrier 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 | 697001662GingivalL5 | 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 9e0186b0-06f2-42e6-9345-9e9c3173d718 61 fields · synced Jun 18, 2026