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Intraoral Digital Impression Instrumen
EUDAMEDClass I (EU MDR)
Ref ELETRA SMARTModel 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 Instrumen 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 EUDAMEDELETRA SMART 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
- 06975136230079 EUDAMED
- Basic UDI-DI
- 697513623PTPANDA001M9 EUDAMED
- Direct Marketing DI
- 06975136230079 EUDAMED
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMEDQ0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Instrumen 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 65efe47f-4325-4168-b7c9-3e582ad7d7ec 61 fields · synced Oct 6, 2026
- EUDAMED 48ea6ab2-e65d-4a64-9978-6d775c785c97 61 fields · synced Sep 18, 2026