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Intraoral Digital Impression Instrument
EUDAMEDFDA UDIClass I (EU MDR)
Ref PANDA freeModel PANDA P2, PANDA P2 Plus, PANDA P3, PANDA P3 Plus, PANDA P4, PANDA smart p, PANDA smart y, PANDA free, PIOS-EX5Ref PANDA P2 PlusRef PANDA P3Ref PIOS-EX5Ref PANDA P2Model 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 FlyRef ZD-l900 Fly
Identity
- Trade Name
- Intraoral Digital Impression Instrument EUDAMEDFreqty FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- 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 free EUDAMEDPANDA P2 Plus EUDAMEDFDA UDIPANDA P3 EUDAMEDFDA UDIPIOS-EX5 EUDAMEDPANDA P2 EUDAMEDFDA UDIPANDA 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 EUDAMEDZD-l900 Fly EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975136230130 EUDAMED06975136230024 EUDAMEDFDA UDI06975136230031 EUDAMEDFDA UDI06975136230154 EUDAMED06975136230017 EUDAMEDFDA UDI06975136230543 EUDAMED
- Basic UDI-DI
- 697513623PTPANDA001M9 EUDAMED
- Direct Marketing DI
- 06975136230130 EUDAMED06975136230024 EUDAMED06975136230031 EUDAMED06975136230154 EUDAMED06975136230017 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY EUDAMEDQ0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Italy EUDAMEDPortugal EUDAMEDNetherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Intraoral Digital Impression Instrument by Ziyang Freqty Medical Equipment Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697513623PTPANDA001M9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (14)
- EUDAMED 1acb89d1-9a0d-4c85-8128-8257e8e535be 61 fields · synced Oct 6, 2026
- EUDAMED e27a65ba-d4c1-4041-8fe8-4bbab7d8c4f9 61 fields · synced May 16, 2026
- EUDAMED 6ebab50b-ff04-43ad-918d-e5db964b93b0 61 fields · synced May 17, 2026
- EUDAMED 5dfaaf63-8f25-4ae5-ac49-38ed354c228a 61 fields · synced May 17, 2026
- EUDAMED cd31af5d-d5cc-4400-ae37-72d6198dd27e 61 fields · synced May 18, 2026
- FDA UDI ea9f77ba-ae2d-4d84-a944-78e9ab99b35a 32 fields · synced May 27, 2026
- FDA UDI 394498da-547b-46c0-b312-c0d9259fa7dd 32 fields · synced May 30, 2026
- FDA UDI 6bf01928-f600-455b-ab0d-4fae29a50162 32 fields · synced May 30, 2026
- EUDAMED c7e5f74f-b1a5-46bf-ac1f-daac7267effd 61 fields · synced Jun 18, 2026
- EUDAMED 1033dacf-ee1f-48ee-9e71-11506a6ac23e 61 fields · synced Jul 9, 2026
- EUDAMED 6269c663-1fb6-4b43-b860-e89c9d199e0a 61 fields · synced Jul 10, 2026
- EUDAMED bd6c788b-4431-432d-b839-4b0169dddaad 61 fields · synced Jul 10, 2026
- EUDAMED cfbff2d9-82b8-4871-9eb6-3191ab504cf1 61 fields · synced Jul 11, 2026
- EUDAMED c0456a62-d24b-4069-9ec3-630ee2fb6c0c 61 fields · synced Jul 25, 2026