Identity
- Device Name
- Dual Barrel Teeth Whitening Gel EUDAMED
- Model / Reference
- GS-HPG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970016625532 EUDAMED
- Basic UDI-DI
- 0697001662GS-HPGYX EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Dual Barrel Teeth Whitening Gel 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 | 0697001662GS-HPGYX | 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 70b5d77b-9e8f-4343-98df-ae75af19c98d 61 fields · synced Jul 10, 2026