En
by Aidite(Qinhuangdao)Technology Co., Ltd. EUDAMED
Active
Ref 98×25-MultilayerModel 95×20-Multilayer
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | Number697645949RMM2B | Date28 May 2026 | StatusActive |
| European Union | CE/MDR | Number697645949RMM2B | Date28 May 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD, CE/MDR Active
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Specification
- Trade Name
- EnPMMA blocks for dental use
- Model / Reference
- 95×20-Multilayer, 98×25-Multilayer
- Primary DI / UDI-DI
- 06934906690413
- Basic UDI-DI
- 697645949RMM2B, B-06934906690413
- EMDN Code
- Q01010101, Q01010199
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000015573
- Authorised representative
- AIDITE Europe GmbH DE-AR-000048785
Other devices from Aidite (Qinhuangdao) Technology Co., Ltd
See all devices from Aidite (Qinhuangdao) Technology Co., Ltd →
Properties
Other properties (12)
- Sterile: No
- Implantable: 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