Shade Plus DSMW10
Part of a family of 80 devices: see the family page
Ref DSMW10
Shade Plus DSMW10 is a Class IIa device made by DMAX Co., Ltd., registered in EUDAMED on 30 Mar 2022 (Basic UDI-DI 88001552SP00ML) with CE/MDR certificate KR26/00000032 valid until 4 Mar 2031, active as of 22 Oct 2026.
Active
CE MDR
Valid until
4 Mar 2031
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberKR26/00000032 | Date4 Mar 2026 | StatusActive |
Official records
- EUDAMED public site 88001552SP00ML
Certificates
- KR26/00000032 Active
Quality management system EU MDR
- Certifier
- SGS Belgium NV 1639
- Issued
- 4 Mar 2026
- Expires
- 4 Mar 2031
Timeline
- Registered EUDAMED 88001552SP00ML
- Certificate issued EUDAMED KR26/00000032
- Certificate expires EUDAMED KR26/00000032
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Dental ceramic block for artificial tooth prostheses
- Model / reference
- DSMW10
- Primary DI / UDI-DI
- 08800155210147
- Basic UDI-DI
- 88001552SP00ML
- EMDN code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- KR-MF-000020635
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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