Identity
- Trade Name
- Helux Pro Surgical Light EUDAMEDFDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Helux Pro Surgical Light EUDAMEDHelux Pro Mobile FDA UDI
- Model / Reference
- 4108120 EUDAMEDFDA UDI
- Description
- Helux Pro Mobile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887761976474 EUDAMEDFDA UDI
- Basic UDI-DI
- 0887761GMN000118UC EUDAMED
- FDA Product Code
- FQP FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
Helux Pro Surgical Light by Baxter Medical Systems GmbH + Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0887761GMN000118UC | 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 e575c18e-c1fc-472a-83df-a58b77e62b5c 61 fields · synced Sep 19, 2026
- FDA UDI b931b638-b858-4737-b2e0-a34d15f0baaf 34 fields · synced May 29, 2026