Identity
- Trade Name
- Portrait HUBXB EUDAMEDFDA UDI
- Generic Name
- Wearable multiple vital physiological parameter monitor FDA UDI
- Device Name
- Portrait HUBXB EUDAMEDPortrait Mobile Patient Monitor Hardware HUBXB FDA UDI
- Model / Reference
- 5923524 EUDAMEDHUBXB FDA UDI
- Description
- Portrait Mobile Patient Monitor Hardware HUBXB FDA UDI
Identifiers
- Catalog Number
- 5923524 FDA UDI
- Primary DI / UDI-DI
- 00195278713193 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00456HT EUDAMED
- 510(k) Number
- K234130 FDA UDI
- FDA Product Code
- MWI FDA UDIBZQ FDA UDIDQA FDA UDIMSX FDA UDIDRG FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Wearable multiple vital physiological parameter monitor FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI868.2375 FDA UDI870.2700 FDA UDI870.2910 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Portrait HUBXB by GE Healthcare Finland Oy — 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 | 8406821BUG00456HT | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- GE Healthcare Finland Oy
- EUDAMED SRN
- FI-MF-000001176
Sources (2)
- EUDAMED 72dc910f-87b8-4488-ab7f-d8c88a8c127b 61 fields · synced Oct 8, 2026
- FDA UDI 78d38342-cf55-4869-a71f-c757184bf8ff 36 fields · synced May 30, 2026