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Oxygen Monitor Sensor Cable

by International Biomedical

Ref 711-1860Model Patient Skin Temperature Sensor

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00850018561570 UDI-DI Date13 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0850018561NxtGenAccT8RG Basic UDI-DI 00850018561570UDI-DIDate29 May 2026RegisteredStatusActive

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.

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  • Withdrawn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
Oxygen Monitor Sensor Cable EUDAMED
NxtGen Infant Transport Incubator GUDID
Generic Name
Transport infant incubator
Device Name
NxtGen Infant Transport Incubator Accessories
Model / Ref / Catalog
Patient Skin Temperature Sensor, 711-1860, O2 Monitor Cable, Incubator
Primary DI / UDI-DI
00850018561570
Basic UDI-DI
0850018561NxtGenAccT8RG
Direct Marketing DI
00850018561570
FDA Product Code
FPL
EMDN Code
Z1203020408 Pulse oximeters
GMDN Term
Transport infant incubator
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5410
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Patient Skin Temperature Sensor
711-1860
GUDID
O2 Monitor Cable, Incubator
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017330
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from International Biomedical, Ltd.

See all devices from International Biomedical, Ltd. →

Properties

  • Measuring Function
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Serial Number: No
  • Expiration Date: No