En
by Aidite(Qinhuangdao)Technology Co., Ltd. 1,000+ variants
Ref 98×25-MultilayerModel 95×20-Multilayer
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
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 |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Trade Name
- EnPMMA blocks for dental use
- Model / Reference
- 95×20-Multilayer, 98×25-Multilayer
- Primary DI / UDI-DI
- 06979046191567, 06978447938887, 06934906690376, 06934906690383, 06978447938856, 06976459499341, 06934906690451, 06976459499273, 06976459499358, 06934906690352, 06934906690512, 06934906690369, 06979046191550, 06976459499389, 06976459499297, 06978447938863, 06976459499365, 06979046191994, 06934906690505, 06934906690444, 06976459499259, 06976459499242, 06934906690529, 06934906690468, 06976459499334, 06976459499280, 06934906690499, 06977585889921, 06976459499303, 06978447938849, 06976459499266, 06976459499327, 06976459499310, 06934906690406, 06979046192229, 06934906690437, 06976459499396
- Basic UDI-DI
- 697645949RMM2B, B-06934906690505, B-06934906690444, B-06976459499259, B-06976459499242, B-06934906690529, B-06976459499389, B-06934906690468, B-06976459499334, B-06976459499280, B-06979046191994, B-06934906690499, B-06976459499297, B-06934906690383, B-06977585889921, B-06978447938856, B-06976459499303, B-06979046191567, B-06934906690352, B-06978447938849, B-06976459499266, B-06976459499327, B-06976459499310, B-06934906690451, B-06976459499365, B-06934906690406, B-06934906690376, B-06979046192229, B-06978447938863, B-06934906690512, B-06934906690437, B-06976459499396, B-06978447938887, B-06976459499358
- EMDN Code
- Q01010101, Q01010199
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000015573
- Authorised representative
- AIDITE Europe GmbH DE-AR-000048785
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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