Tempus Pro 00-1007-R
by Remote Diagnostic Technologies Limited
Ref 00-1007-R / 867421
Tempus Pro 00-1007-R (867421) is a device classified as Class IIb in the EU and Class II in the US made by Remote Diagnostic Technologies Limited, registered in EUDAMED on 11 Mar 2025 (Basic UDI-DI B-05060472442918) and listed in FDA GUDID since 8 Sep 2022 (UDI-DI 05060472442918), active as of 25 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-05060472442918 05060472442918 | Date11 Mar 2025 | StatusActive |
| United States | GUDID listing GUDID | Number05060472442918 | Date8 Sep 2022 | StatusListed |
Official records
- EUDAMED public site B-05060472442918
- AccessGUDID record 05060472442918
Across registries
- EUDAMED Basic UDI-DI B-05060472442918 registered 11 Mar 2025 Active
- FDA GUDID UDI-DI 05060472442918 listed 8 Sep 2022 Listed
Timeline
- Listed FDA GUDID 05060472442918
- Registered EUDAMED B-05060472442918
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Tempus Pro Patient Monitor EUDAMEDTempus Pro GUDID
- Generic name
- Multiple vital physiological parameter monitoring system, clinical
- Device name
- Tempus Pro Vital Signs Monitoring System
- Model / Ref / Catalog
- 00-1007-R / 867421 EUDAMED00-1007-R GUDID867421 GUDID
- Primary DI / UDI-DI
- 05060472442918
- Basic UDI-DI
- B-05060472442918
- FDA product code
- MHX
- EMDN code
- Z1203020202 Transportable/portable multi–parameter patient monitors
- GMDN term
- Multiple vital physiological parameter monitoring system, clinical
- Device class
- Class IIb EUDAMEDClass II GUDID
- Regulation number
- 870.1025
- System or procedure pack
- System which is a device in itself
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 00-1007-R / 867421 | 00-1007-R |
| Device class | Class IIb | Class II |
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