Impression Tray
by Suzhou Puruiang biotechnology co., ltd EUDAMED
Active
Ref Medium UpperModel #1 Large Upper #2 Large Lower #3 Medium Upper #4 Medium Lower #5 Small Upper #6 Small Lower #7 Quadrant UL/LR #8 Quadrant UR/LL #9 Anterior Upper #10 Anterior Lower
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697804313ImpressionTrayXN | Date11 Jun 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Impression Tray
- Model / Reference
- #1 Large Upper #2 Large Lower #3 Medium Upper #4 Medium Lower #5 Small Upper #6 Small Lower #7 Quadrant UL/LR #8 Quadrant UR/LL #9 Anterior Upper #10 Anterior Lower, Medium Upper
- Primary DI / UDI-DI
- 06978043130029
- Basic UDI-DI
- 697804313ImpressionTrayXN
- EMDN Code
- Q010503 Impression material trays, single-use
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000054162
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Suzhou Puruiang biotechnology co., ltd
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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