Identity
- Trade Name
- D6 Mobile EUDAMEDD6 HEXA FDA UDI
- Generic Name
- LED dental light, line-powered FDA UDI
- Device Name
- D6 EUDAMEDThis dental light intended for illuminating inside patient’s mouth for dental use. FDA UDI
- Model / Reference
- D6M EUDAMEDPortable Type FDA UDI
- Description
- This dental light intended for illuminating inside patient’s mouth for dental use. FDA UDI
Identifiers
- Catalog Number
- C-3200 FDA UDI
- Primary DI / UDI-DI
- 08800017900056 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000179OPERATORYLIGHTWH EUDAMED
- Direct Marketing DI
- 08800017900056 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
- Spain 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Operating room light system
D6 Mobile by Dxm Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light system.
- PWDII70DF CL K3 SATX13 — MAQUET SAS · Class I
- PWDII70SF SAT AIM CL K4 12 — MAQUET SAS · Class I
- PWDII50SF AIM MHS021 K4 1116 — MAQUET SAS · Class I
- PWDII55DF CL K4 SAX0810 — MAQUET SAS · Class I
- SLS 9000 — Avante · Class II
- PWDII75SF AIM MHS021 K3 081011 — MAQUET SAS · Class I
- HarmonyAIR — STERIS CORPORATION · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
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 | 88000179OPERATORYLIGHTWH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DXM Co., Ltd.
- EUDAMED SRN
- KR-MF-000016586
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 7e004779-e8f7-4830-a449-5eadf7caa9f1 61 fields · synced Sep 18, 2026
- FDA UDI 8dc781f3-da7d-49e3-bdb0-479baae5fde0 34 fields · synced May 30, 2026