Intraoral Digital Impression Instrument
by Ziyang Freqty Medical Equipment Co., Ltd. 4 variants
Ref DFINE SCAN PLUSModel PANDA P2, PANDA P2 Plus, PANDA P3, PANDA P3 Plus, PANDA P4, PANDA smart p, PANDA smart y, ELETRA SMART, PANDA free, PIOS-EX5, ZD-l900 Fly
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 | Number697513623PTPANDA001M9 | Date15 Jun 2022 | StatusActive |
Certificates
No notified-body 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- Withdrawn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
- Model / Reference
- PANDA P2, PANDA P2 Plus, PANDA P3, PANDA P3 Plus, PANDA P4, PANDA smart p, PANDA smart y, ELETRA SMART, PANDA free, PIOS-EX5, ZD-l900 Fly, DFINE SCAN PLUS
- Primary DI / UDI-DI
- 06975136230802
- Basic UDI-DI
- 697513623PTPANDA001M9
- EMDN Code
- Q0199 Odontology devices - other
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000019421
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Ziyang Freqty Medical Equipment 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