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M1194A Reus A-P Ear Clp SpO2 Sensr 1.5m

by Philips Medizin Systeme Böblingen GmbH

Ref 989803205891

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

CE MDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884838102712 Basic UDI-DI 00884838102712UDI-DIDate16 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838102712 UDI-DI Date28 Jan 2022ListedStatusListed 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.

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  • Withdrawn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
M1194A Reus A-P Ear Clp SpO2 Sensr 1.5m EUDAMED
SpO2 Sensor GUDID
Generic Name
Pulse oximeter probe, reusable
Device Name
SPO2 Sensors
Model / Ref / Catalog
989803205891, M1194A Reus A-P Ear Clp SpO2 Sensr 1.5m
Primary DI / UDI-DI
00884838102712
Basic UDI-DI
B-00884838102712
FDA Product Code
DQA
EMDN Code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN Term
Pulse oximeter probe, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2700
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
989803205891
GUDID
M1194A Reus A-P Ear Clp SpO2 Sensr 1.5m
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Related devices

Category: Electrical-only medical device connection cable, reusable

Other devices from Philips Medizin Systeme Böblingen GmbH

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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