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S300 Series
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref D-C-LVSL-V5-202602-ENGModel S300
Identity
- Trade Name
- S300 Series FDA UDI
- Generic Name
- Operating room light system FDA UDI
- Device Name
- Surgical Luminaire EUDAMEDAC 100-240V, 50/60Hz, 77-120VA FDA UDI
- Model / Reference
- S300 EUDAMEDD-C-LVSL-V5-202602-ENG EUDAMEDS300-22100 FDA UDI
- Description
- AC 100-240V, 50/60Hz, 77-120VA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800053094030 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000530S300F5 EUDAMED
- FDA Product Code
- FTD FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- Operating room light system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Poland 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
Yes
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
S300 Series by Dentis Co. , Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
Sources (2)
- FDA UDI 412814d7-285c-4290-b97d-b08bb1100eb5 33 fields · synced Jun 19, 2026
- EUDAMED 040bee54-5ffe-4a02-af00-daa8dd8012ab 61 fields · synced Jun 19, 2026