Identity
- Trade Name
- i2i Real-Time Telemedicine Response Centre Software EUDAMEDTempus IC2 FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- i2i Real-Time Telemedicine Response Centre Software EUDAMED
- Model / Reference
- 01-2506 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060472440433 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060472440433 EUDAMED
- FDA Product Code
- MWI FDA UDI
- EMDN Code
- Z1203020282 MULTI-PARAMETER MONITORS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Tempus IC2 by Remote Diagnostic Technologies Limited — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Remote Diagnostic Technologies Limited
Sources (2)
- FDA UDI 3907bcee-7efd-446a-8c49-3718aee32363 33 fields · synced Jul 27, 2026
- EUDAMED 0674a3e2-2206-4636-bddb-5a18b4d3d881 61 fields · synced Jul 27, 2026