TruLight 5000 / 3000 Ceiling Trio

by Baxter Medical Systems GmbH + Co. KG

Ref 4038310

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR EUDAMED	Number0887761GMN000021TU Basic UDI-DI 00887761968394UDI-DI	Date1 Dec 2025Registered	StatusActive
United States	GUDID listing GUDID	Number00887761968394 UDI-DI	Date5 Jan 2023Listed	StatusListed 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

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: TruLight 5000 / 3000 Ceiling Trio EUDAMED
TL 5000/3000 – Surgical Light GUDID
Generic Name: Operating room light
Device Name: TruLight 5000 / 3000 - Surgical light
Model / Reference: 4038310

Primary DI / UDI-DI: 00887761968394
Basic UDI-DI: 0887761GMN000021TU
FDA Product Code: FQP, FSY, FSQ, FTD
EMDN Code: Z12010701 Fixed scialytic lamps
GMDN Term: Operating room light

Device Class: Class I EUDAMED
Class II GUDID
Regulation Number: 878.4580
EU market of registration: Germany
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 1 field differs

Field	EUDAMED	GUDID
Device Class	EUDAMED Class I	GUDID Class II

Manufacturer details

EUDAMED SRN: DE-MF-000005071

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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