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Portrait HUB01

by GE Healthcare Finland Oy

Ref 2096437-001

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278093998 UDI-DI Date1 Sep 2023ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00259HP Basic UDI-DI 00195278093998UDI-DIDate31 Mar 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3038-2026 FDA Class II initiated 20 Jul 2026

    Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Wearable multiple vital physiological parameter monitor
Device Name
Portrait Mobile Patient Monitor
Model / Ref / Catalog
2096437-001, HUB01
Primary DI / UDI-DI
00195278093998
Basic UDI-DI
8406821BUG00259HP
Direct Marketing DI
00195278093998
510(k) Number
FDA Product Code
MSX, MWI, DQA, BZQ, DRG
EMDN Code
Z1203020202 Transportable/portable multi–parameter patient monitors
GMDN Term
Wearable multiple vital physiological parameter monitor
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2300, 870.2700, 868.2375, 870.2910
EU market of registration
Finland
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
2096437-001
GUDID
HUB01
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000001176

Other devices from GE Healthcare Finland Oy

See all devices from GE Healthcare Finland Oy →

Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No