Teeth Whitening Kit
by Zhengzhou Huaer Electro-optics Technology Co, Ltd.
Ref 06974041280360Model HR-BHK01,HR-BHK02,HR-BHK03,HR-BHK04,HR-BHK05,HR-BHK06,HR-BHK07
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697404128TWK002M8 06974041280360 | Date21 May 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Teeth Whitening Kit
- Model / Reference
- HR-BHK01, HR-BHK02, HR-BHK03, HR-BHK04, HR-BHK05, HR-BHK06, HR-BHK07, 06974041280360
- Primary DI / UDI-DI
- 06974041280360
- Basic UDI-DI
- 697404128TWK002M8
- EMDN Code
- V9099 Various devices not included in other classes - other
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- CN-MF-000003166
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No