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Teeth Whitening System
EUDAMEDClass I (EU MDR)
Ref 758124Model 658124Ref 658113
Identity
- Trade Name
- Teeth Whitening System EUDAMED
- Device Name
- Teeth Whitening System EUDAMED
- Model / Reference
- 658124 EUDAMED758124 EUDAMED658113 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977478780021 EUDAMED06977478780038 EUDAMED06977478780014 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 (3)
- EUDAMED d551fd03-1342-4ee4-8d5d-4221ffb50064 61 fields · synced Aug 1, 2026
- EUDAMED 07513429-799c-4de4-99c9-a8c600dc5889 61 fields · synced May 18, 2026
- EUDAMED 40ad7f95-4584-4542-8815-7e80595d7609 61 fields · synced May 18, 2026