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TruLight 5000 / 3000 – Surgical Light
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4038130
Identity
- Trade Name
- TruLight 5000 / 3000 – Surgical Light EUDAMEDTL 5000/3000 – Surgical Light FDA UDI
- Generic Name
- Operating room light system FDA UDI
- Device Name
- TruLight 5000 / 3000 - Surgical light EUDAMEDTruLight 5000 / 3000 Wall FDA UDI
- Model / Reference
- 4038130 EUDAMEDFDA UDI
- Description
- TruLight 5000 / 3000 Wall FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887761968424 EUDAMEDFDA UDI
- Basic UDI-DI
- 0887761GMN000021TU EUDAMED
- FDA Product Code
- IWY FDA UDIJEA FDA UDIKXJ FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Operating room light system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1920 FDA UDI878.4960 FDA UDI892.1980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light system
TruLight 5000 / 3000 – Surgical Light by Baxter Medical Systems GmbH + Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0887761GMN000021TU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Baxter Medical Systems GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005071
Sources (2)
- EUDAMED 26b16595-de01-4527-98a3-7d7dbed0baa9 61 fields · synced Sep 19, 2026
- FDA UDI 405b6973-c72c-48aa-943d-7c47741ee100 35 fields · synced May 30, 2026