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SedLine Module

by Philips Medizin Systeme Böblingen GmbH

Ref 867186

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

CE MDD

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 Number00884838086678 UDI-DI Date15 Jan 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-00884838086678 Basic UDI-DI 00884838086678UDI-DIDate30 May 2025RegisteredStatusActive

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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SedLine Module EUDAMED
Masimo Sedline Module GUDID
Generic Name
Patient monitoring system module, interfacing
Model / Ref / Catalog
867186, SedLine Module
Primary DI / UDI-DI
00884838086678
Basic UDI-DI
B-00884838086678
510(k) Number
FDA Product Code
MHX
EMDN Code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN Term
Patient monitoring system module, interfacing
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.1025
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
867186
GUDID
SedLine Module
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

See all devices from Philips Medizin Systeme Böblingen GmbH →

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