Medicaline Mouthguard
by Zhengzhou Huaer Electro-optics Technology Co, Ltd.
Ref 697404128HRVF01L9, 697404128HZPR01PKModel ML89068, ML89061, ML89062, ML89069
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06974041280575 | Date29 Apr 2026 | 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- Withdrawn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/MDD Active
Specification
- Model / Reference
- ML89068, 697404128HRVF01L9, ML89061, 697404128HZPR01PK, ML89062, ML89069
- Primary DI / UDI-DI
- 06974041280575, 06974041280544, 06974041280551, 06974041280568
- Basic UDI-DI
- B-06974041280575, B-06974041280544, B-06974041280551, B-06974041280568
- EMDN Code
- Q0199 Odontology devices - 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 (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No