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Intraoral Digital Impression Instrument
EUDAMEDClass I (EU MDR)
Ref PANDA P3 PlusModel PANDA P2, PANDA P2 Plus, PANDA P3, PANDA P3 Plus, PANDA P4, PANDA smart p, PANDA smart y, PANDA free, PIOS-EX5Model 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
Identity
- Trade Name
- Intraoral Digital Impression Instrument EUDAMED
- Device Name
- Intraoral Digital Impression Instrument EUDAMED
- Model / Reference
- PANDA P2, PANDA P2 Plus, PANDA P3, PANDA P3 Plus, PANDA P4, PANDA smart p, PANDA smart y, PANDA free, PIOS-EX5 EUDAMEDPANDA P3 Plus EUDAMEDPANDA 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 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975136230147 EUDAMED
- Basic UDI-DI
- 697513623PTPANDA001M9 EUDAMED
- Direct Marketing DI
- 06975136230147 EUDAMED
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMEDQ0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Intraoral Digital Impression Instrument by Ziyang Freqty Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697513623PTPANDA001M9 | Class I | Active |
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Manufacturer
- Manufacturer
- Ziyang Freqty Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000019421
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED cc1baf10-9375-491e-b0e1-421b8d5db47a 61 fields · synced Oct 7, 2026
- EUDAMED 22ea8c69-587c-41e8-a758-044e9d975af5 61 fields · synced Oct 6, 2026