Skip to content

TruLight 1000 preinstallation set

by Baxter Medical Systems GmbH + Co. KG

Ref 4058051

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 Number0887761GMN000030TV Basic UDI-DI 00887761968370UDI-DIDate18 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00887761968370 UDI-DI Date15 Dec 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TruLight 1000 preinstallation set EUDAMED
TL 1000 Preinstallation set GUDID
Generic Name
Medical device rail
Device Name
Pre-Install Set
Model / Reference
4058051
Primary DI / UDI-DI
00887761968370
Basic UDI-DI
0887761GMN000030TV
FDA Product Code
KZF
EMDN Code
Z12010799 Scialytic lamp lighting systems - other
GMDN Term
Medical device rail
Device Class
Class I
Regulation Number
880.6320
EU market of registration
Germany
GUDID distribution status
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