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Frame F5-01

by GE Healthcare Finland Oy

Ref M1115512Model FRAME F5-01

Active European Union. Also listed in GUDID (US).

CE MDD

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
European UnionCE/MDD EUDAMED NumberB-00840682103992 Basic UDI-DIDate30 Nov 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682103992 UDI-DIDate3 Jun 2016ListedStatusListed GUDID: in commercial distribution

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-0453-2026 FDA Class II initiated 26 Sep 2025

    Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
F5-01
Generic Name
Patient monitoring system module rack
Device Name
E-module Frames
Model / Ref / Catalog
FRAME F5-01, M1115512
Primary DI / UDI-DI
00840682103992
Basic UDI-DI
B-00840682103992, 8406821BUG00187HP
510(k) Number
FDA Product Code
DSJ, BZQ, MLD, ORT, MHX, NHP, DPZ, OLW, CBQ, FLL, DPS, KOI, NHQ, DXG, CBS, GWJ, NHO, DQK, CBR, GWQ, CCK, DSK, OLT, CAP, DQA, CCL, KRB, BZL, DRT, OMC, DSI, DXN, BZK
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Patient monitoring system module rack
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1100, 868.2375, 870.1025, 882.1400, 868.1500, 870.2710, 880.2910, 870.2340, 868.2775, 870.1435, 868.1620, 882.1900, 870.1425, 868.1700, 868.1400, 870.1110, 868.2600, 870.2700, 868.1720, 870.1915, 868.1730, 870.2300, 870.1130, 868.1850
Market of Registration
Finland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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

  • Prescription Use
  • Serial Number
  • Manufacturing Date

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
  • Measuring Function: 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