DDGM Self-Molding Night Guard – Small
by Zhengzhou Huaer Electro-optics Technology Co, Ltd. EUDAMED
Active
Ref DDGM-BITE-BL-SModel BTDDGM-01S
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697404128TWK02LJ | Date12 Aug 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- BTDDGM-01S, DDGM-BITE-BL-S
- Primary DI / UDI-DI
- 06974041281107
- Basic UDI-DI
- 697404128TWK02LJ
- EMDN Code
- Q010399 Surgical dental devices - other
- Device Class
- Class I
- Market of Registration
- Italy
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