Identity
- Trade Name
- DCI Edge FDA UDI
- Generic Name
- LED dental light, line-powered FDA UDI
- Device Name
- LIGHT EUDAMEDCeiling Mount Series 5 Light, 120 Volt, White FDA UDI
- Model / Reference
- LIGHT EUDAMEDLC5 FDA UDI
- Description
- Ceiling Mount Series 5 Light, 120 Volt, White FDA UDI
Identifiers
- Catalog Number
- LC5000 FDA UDI
- Primary DI / UDI-DI
- 00810021436951 EUDAMEDFDA UDI
- Basic UDI-DI
- 081002143lightKD EUDAMED
- Direct Marketing DI
- 00810021436951 EUDAMED
- FDA Product Code
- EAZ FDA UDI
- EMDN Code
- Z12010701 FIXED SCIALYTIC LAMPS EUDAMED
- GMDN Term
- LED dental light, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4630 FDA UDI
- Market of Registration
- France 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light system
Light by DCI International, LLC — 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 | 081002143lightKD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DCI International, LLC
- EUDAMED SRN
- US-MF-000022306
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 22489294-079b-4bea-b261-d601ea10ff28 61 fields · synced Jun 18, 2026
- FDA UDI 4e17697b-2b88-43e0-b0db-73ef908fcb7f 35 fields · synced May 30, 2026