Identity
- Trade Name
- Teeth Whitening System EUDAMED
- Device Name
- Teeth Whitening System EUDAMED
- Model / Reference
- 658124 EUDAMED758113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977478780045 EUDAMED
- Basic UDI-DI
- 697747878658124CP EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Teeth Whitening System by Grandee Electric Appliance (ShenZhen) Limited — 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 | 697747878658124CP | Class I | Active |
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Manufacturer
- Manufacturer
- Grandee Electric Appliance (ShenZhen) Limited
- EUDAMED SRN
- CN-MF-000042303
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 20e04803-7bc1-486a-b0d2-609c5822d9ae 61 fields · synced Jun 18, 2026