Identity
- Trade Name
- Tempus Pro Printer Paper with 110mm Grid EUDAMEDTempus Pro FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- Gridded Printer Paper EUDAMEDTempus Pro - Printer Paper with 110mm grid FDA UDI
- Model / Reference
- 01-2186 EUDAMEDFDA UDI
- Description
- Tempus Pro - Printer Paper with 110mm grid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060472441140 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060472441140 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z12050385 ELECTROCARDIOGRAPHS - CONSUMABLES EUDAMED
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Multiple vital physiological parameter monitoring system, clinical
Tempus Pro by Remote Diagnostic Technologies Limited — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple vital physiological parameter monitoring system, clinical.
- Ultraview SL® — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Nightingale Monitoring System — ZOE MEDICAL INCORPORATED · Class II
- Comen — Shenzhen Comen Medical Instruments Co., LTD. · Class II
- Lutech — Lutech Industries · Class II
- Lutech — Lutech Industries · Class II
- Lutech — Lutech Industries · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Lutech — Lutech Industries · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 07cdfc5f-93a2-4b5a-99fe-e1b237f4019b 33 fields · synced Jun 20, 2026
- EUDAMED f3ded8b5-0f90-45a2-86de-bcbae1295f0d 61 fields · synced Jun 20, 2026