Identity
- Trade Name
- 2-Channel Invasive Pressure Module EUDAMEDTempus Pro FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
- Device Name
- 2-Channel Invasive Pressure Module EUDAMEDFDA UDI
- Model / Reference
- 01-2017 EUDAMEDFDA UDI
- Description
- 2-Channel Invasive Pressure Module FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060472440112 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060472440112 EUDAMED
- FDA Product Code
- MHX FDA UDI
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Multiple vital physiological parameter monitoring system, clinical FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Denmark 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
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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 |
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Manufacturer
- Manufacturer
- Remote Diagnostic Technologies Limited
Sources (2)
- FDA UDI 23dd23a5-4d25-45ba-bc80-fa23edc03b27 33 fields · synced Jul 12, 2026
- EUDAMED 2f5d2c35-1f68-46a0-ac92-2cf36d7698d6 61 fields · synced Jun 14, 2026