Aidite COLOR
by Aidite (Qinhuangdao) Technology Co., Ltd.
Ref 92×75×14-COLORModel COLOR, STC, SHTPC, SHT-Plus
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | Number697645949ZCCZW 06975367005033 | Date28 May 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number697645949ZCCZW 06975367005033 | Date28 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number06975367005033 | Date1 Dec 2022 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- En EUDAMEDDental Zirconia Ceramic EUDAMEDAidite GUDID
- Generic Name
- Dental appliance fabrication material, ceramic
- Model / Reference
- COLOR, STC, SHTPC, SHT-Plus, 92×75×14-COLOR
- Primary DI / UDI-DI
- 06975367005033
- Basic UDI-DI
- 697645949ZCCZW, B-06975367005033
- FDA Product Code
- EIH
- EMDN Code
- Q01010101, Q01010199
- GMDN Term
- Dental appliance fabrication material, ceramic
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 872.6660
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | COLOR, STC, SHTPC, SHT-Plus 92×75×14-COLOR | COLOR |
| Device Class | Class IIa | Class II |
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Properties
Other properties (19)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No