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B105P Patient Monitor

by GE Medical Systems Information Technologies, Inc. 2 variants

Ref 6160000-101Model B105P

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00195278488473 UDI-DI Date13 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8406821BUG00323H7 Basic UDI-DI 00195278488473UDI-DIDate26 Jan 2023RegisteredStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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

Trade Name
B105P Patient Monitor EUDAMED
B105P GUDID
Generic Name
General-purpose multi-parameter bedside monitor
Model / Ref / Catalog
B105P, 6160000-101, B105P Patient Monitor
Primary DI / UDI-DI
00195278488473
Basic UDI-DI
8406821BUG00323H7
510(k) Number
FDA Product Code
CBQ, MHX, OLT, BZQ, KRB, FLL, NHP, CBR, CBS, ORT, DQK, GWO, OLW, CCK, CCL, DXN, DQA, DSJ, DSK, NHO, DRT, OMC, DPZ, KOI, NHQ, MLD, DSI
EMDN Code
Z1203020201 Multi–parameter patient bedside monitors
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.1500, 870.1025, 882.1400, 868.2375, 870.1915, 880.2910, 868.1700, 868.1620, 870.1425, 882.5320, 868.1400, 868.1720, 870.1130, 870.2700, 870.1100, 870.1110, 870.2300, 870.2710, 868.2775
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
B105P
6160000-101
GUDID
B105P Patient Monitor
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017529
Authorised representative
GE Medical Systems SCS FR-AR-000000344

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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