implant prosthetic kit
by Foshan Topmed Dental Co., Ltd 8 variants
Ref TM-PRK-CModel TM-PRK-E ,TM-SGT04 ,TM-SGT03 ,TM-SGT05,TM-SGT01,TOP WRENCH ，TM-D0007X,TM-PRK-C ，TM-D0010
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number698014095ipkYV 06980140954088 | Date26 Aug 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- implant prosthetic kit
- Model / Reference
- TM-PRK-E, TM-SGT04, TM-SGT03, TM-SGT05, TM-SGT01, TOP WRENCH ，TM-D0007X, TM-PRK-C ，TM-D0010, TM-PRK-C
- Primary DI / UDI-DI
- 06980140954088
- Basic UDI-DI
- 698014095ipkYV
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class I
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000057253
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Foshan Topmed Dental Co., Ltd
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