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Wireless SpO2 3.0 Module (Networks 6-10)

by Philips Medizin Systeme Böblingen GmbH

Ref 989803194331Model Wireless ECG/SpO2 Gen 3 Modules

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM1080LZ Basic UDI-DI 00884838111455UDI-DIDate2 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838111455 UDI-DI Date2 Jun 2025ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Wireless SpO2 3.0 Module (Networks 6-10) EUDAMED
MR Patient Care Wireless SpO2 3.0 Module (Networks 6-10) GUDID
Generic Name
Patient monitoring system module, pulse oximetry
Device Name
Wireless ECG/SpO2 Gen 3 Modules
Model / Ref / Catalog
Wireless ECG/SpO2 Gen 3 Modules, 989803194331, Wireless SpO2 3.0 Module (Networks 6-10)
Primary DI / UDI-DI
00884838111455
Basic UDI-DI
0884838BM1080LZ
Direct Marketing DI
00884838111455
FDA Product Code
MWI
EMDN Code
Z1203020299 Multi–parameter monitors - other
GMDN Term
Patient monitoring system module, pulse oximetry
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2300
EU 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
Wireless ECG/SpO2 Gen 3 Modules
989803194331
GUDID
Wireless SpO2 3.0 Module (Networks 6-10)
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Other devices from Philips Medizin Systeme Böblingen GmbH

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Properties

  • Measuring Function
  • Prescription Use
  • Serial Number

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
  • 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