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MR Patient Care SpO2 Sensor

by Philips Medizin Systeme Böblingen GmbH EUDAMEDGUDID

Active European Union

Ref 989803161991

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00884838111370 UDI-DIDate30 May 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0884838BM1077MC Basic UDI-DIDate29 May 2025RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 6 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
SpO2 Sensor EUDAMED
MR Patient Care SpO2 Sensor GUDID
Generic Name
Pulse oximeter probe, reusable
Device Name
Reusable SpO2 Probes
Model / Ref / Catalog
989803161991, SpO2 Sensor
Primary DI / UDI-DI
00884838111370
Basic UDI-DI
0884838BM1077MC
Direct Marketing DI
00884838111370
FDA Product Code
MWI
EMDN Code
Z1203020299 Multi–parameter monitors - other
GMDN Term
Pulse oximeter probe, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2300
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
989803161991
GUDID
SpO2 Sensor
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • 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
  • Manufacturing Date: No