Identity
- Trade Name
- Visionflex FDA UDI
- Generic Name
- Patient monitoring system module, data memory FDA UDI
- Device Name
- ProEX Telehealth Hub System GEIS - CLIN - v3 FDA UDI
- Model / Reference
- VFPROEX23.03 FDA UDI
- Description
- ProEX Telehealth Hub System GEIS - CLIN - v3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09352527001185 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
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
Category: Patient monitoring system module, data memory
Visionflex by Visionflex Pty. Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, data memory.
- HEARTMATE®, DATA CARD — Thoratec Corp · Class III
- Tempo Smart Button — ELI LILLY AND COMPANY · Class II
- Visionflex — VISIONFLEX PTY. LTD. · Class I
- Visionflex — VISIONFLEX PTY. LTD. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Visionflex Pty. Ltd.
Sources (1)
- FDA UDI cd2b38ce-f5dd-4468-b2ec-931bcd81b20f 33 fields · synced May 29, 2026