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Intraoral Digital Impression Instrument
EUDAMEDFDA UDIClass I (EU MDR)
Ref PANDA smart yModel PANDA P2, PANDA P2 Plus, PANDA P3, PANDA P3 Plus, PANDA P4, PANDA smart p, PANDA smart y, PANDA free, PIOS-EX5
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 smart y EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975136230062 EUDAMEDFDA UDI
- Basic UDI-DI
- 697513623PTPANDA001M9 EUDAMED
- Direct Marketing DI
- 06975136230062 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Z11030402 SYSTEMS FOR INTRAORAL DIGITAL VIDEORADIOGRAPHY 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
- Poland 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 (2)
- EUDAMED 7c9f5872-3109-418b-b8d5-86e5cc0e3ad2 61 fields · synced Jun 17, 2026
- FDA UDI aa73039a-8d0a-4dbe-ace5-8b970ec2c3be 32 fields · synced May 30, 2026