Identity
- Trade Name
- UbiqVue 1AX Wearable Biosensor EUDAMEDUbiqVue Multiparameter FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, single-use FDA UDI
- Device Name
- UbiqVue 1AX Wearable Biosensor EUDAMED1AX Wearable Biosensor FDA UDI
- Model / Reference
- UB1550 EUDAMEDFDA UDI
- Description
- 1AX Wearable Biosensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- ++B353UB1550KS EUDAMEDB353UB15501 FDA UDI
- Basic UDI-DI
- ++B353UX1550TC EUDAMED
- FDA Product Code
- DRG FDA UDIFLL FDA UDIMHX FDA UDI
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
- GMDN Term
- Wearable multiple physiological parameter recorder, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2910 FDA UDI880.2910 FDA UDI870.1025 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
UbiqVue 1AX Wearable Biosensor by LifeSignals, Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++B353UX1550TC | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- LifeSignals, Inc.
- EUDAMED SRN
- US-MF-000033437
- Authorised Representative
- Renew Health Ltd. IE-AR-000013707
Sources (2)
- EUDAMED 4bd4fced-80fe-4d05-a298-751a510695d6 61 fields · synced Jun 18, 2026
- FDA UDI 6b5269c0-5644-47a5-afd0-c05d084058b0 35 fields · synced May 30, 2026