Identity
- Trade Name
- PaX-i Plus EUDAMEDFDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- Digital X-ray Imaging System EUDAMEDDental Digital X-ray Imaging System functioning Pano Image Acquisition FDA UDIDental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition FDA UDI
- Model / Reference
- PCH-30CS EUDAMEDFDA UDIVDH-UM-070 EUDAMED
- Description
- Dental Digital X-ray Imaging System functioning Pano Image Acquisition FDA UDIDental Digital X-ray Imaging System functioning Pano/Ceph(scan type) Image Acquisition FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016400427 EUDAMEDFDA UDI08800016400434 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000164PCH30CS070X3 EUDAMED
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary panoramic/tomographic dental x-ray system, digital
PaX-i Plus by Vatech Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vatech Co., Ltd.
Sources (4)
- FDA UDI 2df98afc-311a-4eb6-9a7a-c251ed52db07 34 fields · synced Aug 3, 2026
- FDA UDI fefeed0e-fb68-4481-900c-e2949d901413 34 fields · synced May 30, 2026
- EUDAMED b3911e1a-b10e-4d52-8b5b-dc647afa0be1 61 fields · synced Jul 12, 2026
- EUDAMED 43e87f14-140c-4bba-bba5-529483263982 61 fields · synced Aug 3, 2026