Identity
- Trade Name
- UbiqVue Multiparameter, UbiqVue EUDAMEDUbiqVue Multiparameter FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, single-use FDA UDI
- Device Name
- UbiqVue 2A Wearable Biosensor EUDAMED2A Wearable Biosensor FDA UDI
- Model / Reference
- UB2550 EUDAMEDFDA UDI
- Description
- 2A Wearable Biosensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- +B353UB25501/$$+7BIV0ASLLNNNNNXXXXX/16DYYYYMMDD/14DZZZZMMDD/Q1J EUDAMEDB353UB25501 FDA UDI
- Basic UDI-DI
- ++B353UB2550KZ EUDAMED
- FDA Product Code
- DRG FDA UDIFLL FDA UDIMHX FDA UDIDQA FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES 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 UDI870.2700 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
Yes
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 Multiparameter, UbiqVue 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 | ++B353UB2550KZ | 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 ebf50481-50de-4c3b-ba08-2578be671a07 61 fields · synced May 31, 2026
- FDA UDI 0cb76706-46eb-4526-bc1e-a8c5e12fbaff 35 fields · synced May 30, 2026