Identity
- Trade Name
- Visionflex FDA UDI
- Generic Name
- Patient monitoring system module, data memory FDA UDI
- Device Name
- The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all over the world to confidently carry out detailed medical examinations on patients based in regional, remote, rural and urban areas. FDA UDI
- Model / Reference
- VFPROEX21.02 FDA UDI
- Description
- The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all over the world to confidently carry out detailed medical examinations on patients based in regional, remote, rural and urban areas. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09352527000553 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Patient monitoring system module, data memory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, data memory
Visionflex by Visionflex Pty. Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Visionflex — VISIONFLEX PTY. LTD. · Class I
- Visionflex — VISIONFLEX PTY. LTD. · Class I
- Visionflex — VISIONFLEX PTY. LTD. · Class I
- Visionflex — VISIONFLEX PTY. LTD. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Visionflex Pty. Ltd.
Sources (1)
- FDA UDI fab71dc0-ca80-42cb-ac8f-8245bac2effd 33 fields · synced May 30, 2026