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Control Units

by Baxter Medical Systems GmbH + Co. KG 5 variants

Ref 1549939

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0887761GMN000004TU Basic UDI-DI 00887761974517UDI-DIDate6 Apr 2026RegisteredStatusActive EUDAMED: not on the EU market
United StatesGUDID listing GUDID Number00887761974517 UDI-DI Date11 Jan 2023ListedStatusListed GUDID: not 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  • Withdrawn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

Generic Name
Operating room equipment remote control
Model / Reference
1549939
Primary DI / UDI-DI
00887761974517
Basic UDI-DI
0887761GMN000004TU
FDA Product Code
GDC, KXJ, JEA
EMDN Code
Z12011280 Patient positioning instruments - hardware accessories
GMDN Term
Operating room equipment remote control
Device Class
Class I
Regulation Number
878.4960, 892.1980
GUDID distribution status
Not in Commercial Distribution

Manufacturer details

EUDAMED SRN
DE-MF-000005071

Other devices from Baxter Medical Systems GmbH + Co. KG

See all devices from Baxter Medical Systems GmbH + Co. KG →

Properties

  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No