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LED Surgical Light
EUDAMEDClass I (EU MDR)
Ref L6SCBRef L9B-DC/L9B-DCModel L1Ref L5-DCCRef L1DCRef L8BRef L3-SCARef L5-SCBRef L8A/L7Ref L9BRef L8B-DC/L8B-DCRef L3-BRef L5-CRef L7-DC/L7-DCRef L6-SCBRef L6-DRef L9B-SC/L9B-SCRef L8B-QC/L8A-QCRef L3-ARef L5-DCRef L8B/L8B/L7Ref L8B/L8B/L8ARef L5-DCBRef L6Ref L8B/L8BRef L9B/L9BRef L6-DCCRef L6SCRef L5-SCRef L8A-DC/L7-DCRef L8A/L8A/L7Ref L8A-SC/L7-SCRef L6-CRef L8B-DC/L8A-DCRef L6-DCBRef L5-SCCRef L3-DCARef L7-SCRef L9B-DCRef L5-DCDRef L8A-QC/L7-QCRef L5-DRef L9B-SCRef L8ARef L6ARef L6-BRef L8A-SCRef L7-SC/L7-SCRef L7-QC/L7-QCRef L9ARef L3-SC
Identity
- Trade Name
- LED Surgical Light EUDAMED
- Device Name
- LED Surgical Light EUDAMED
- Model / Reference
- L6SCB EUDAMEDL1 EUDAMEDL9B-DC/L9B-DC EUDAMEDL5-DCC EUDAMEDL1DC EUDAMEDL8B EUDAMEDL3-SCA EUDAMEDL5-SCB EUDAMEDL8A/L7 EUDAMEDL9B EUDAMEDL8B-DC/L8B-DC EUDAMEDL3-B EUDAMEDL5-C EUDAMEDL7-DC/L7-DC EUDAMEDL6-SCB EUDAMEDL6-D EUDAMEDL9B-SC/L9B-SC EUDAMEDL8B-QC/L8A-QC EUDAMEDL3-A EUDAMEDL5-DC EUDAMEDL8B/L8B/L7 EUDAMEDL8B/L8B/L8A EUDAMEDL5-DCB EUDAMEDL6 EUDAMEDL8B/L8B EUDAMEDL9B/L9B EUDAMEDL6-DCC EUDAMEDL6SC EUDAMEDL5-SC EUDAMEDL8A-DC/L7-DC EUDAMEDL8A/L8A/L7 EUDAMEDL8A-SC/L7-SC EUDAMEDL6-C EUDAMEDL8B-DC/L8A-DC EUDAMEDL6-DCB EUDAMEDL5-SCC EUDAMEDL3-DCA EUDAMEDL7-SC EUDAMEDL9B-DC EUDAMEDL5-DCD EUDAMEDL8A-QC/L7-QC EUDAMEDL5-D EUDAMEDL9B-SC EUDAMEDL8A EUDAMEDL6A EUDAMEDL6-B EUDAMEDL8A-SC EUDAMEDL7-SC/L7-SC EUDAMEDL7-QC/L7-QC EUDAMEDL9A EUDAMEDL3-SC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429022384 EUDAMED06945429029116 EUDAMED06945429029345 EUDAMED06945429029901 EUDAMED06945429062052 EUDAMED06945429029215 EUDAMED06945429029383 EUDAMED06945429062267 EUDAMED06945429029031 EUDAMED06945429062168 EUDAMED06945429029192 EUDAMED06945429029291 EUDAMED06945429062328 EUDAMED06945429029543 EUDAMED06945429029468 EUDAMED06945429029109 EUDAMED06945429062212 EUDAMED06945429029185 EUDAMED06945429029314 EUDAMED06945429062359 EUDAMED06945429062342 EUDAMED06945429029338 EUDAMED06945429021530 EUDAMED06945429062144 EUDAMED06945429029093 EUDAMED06945429029413 EUDAMED06945429029505 EUDAMED06945429022360 EUDAMED06945429029369 EUDAMED06945429062281 EUDAMED06945429062366 EUDAMED06945429062274 EUDAMED06945429029451 EUDAMED06945429062205 EUDAMED06945429029499 EUDAMED06945429029390 EUDAMED06945429029246 EUDAMED06945429062120 EUDAMED06945429029055 EUDAMED06945429029352 EUDAMED06945429062298 EUDAMED06945429029307 EUDAMED06945429029048 EUDAMED06945429062083 EUDAMED06945429021547 EUDAMED06945429029444 EUDAMED06945429062090 EUDAMED06945429062311 EUDAMED06945429062335 EUDAMED06945429029000 EUDAMED06945429029208 EUDAMED
- Basic UDI-DI
- B-06945429022384 EUDAMED69454290SL003Q8 EUDAMED69454290SL004QA EUDAMEDB-06945429021530 EUDAMEDB-06945429022360 EUDAMEDB-06945429021547 EUDAMED
- Direct Marketing DI
- 06945429029116 EUDAMED06945429029345 EUDAMED06945429029901 EUDAMED06945429062052 EUDAMED06945429029215 EUDAMED06945429029383 EUDAMED06945429062267 EUDAMED06945429029031 EUDAMED06945429062168 EUDAMED06945429029192 EUDAMED06945429029291 EUDAMED06945429062328 EUDAMED06945429029543 EUDAMED06945429029468 EUDAMED06945429029109 EUDAMED06945429062212 EUDAMED06945429029185 EUDAMED06945429029314 EUDAMED06945429062359 EUDAMED06945429062342 EUDAMED06945429029338 EUDAMED06945429062144 EUDAMED06945429029093 EUDAMED06945429029413 EUDAMED06945429029505 EUDAMED06945429029369 EUDAMED06945429062281 EUDAMED06945429062366 EUDAMED06945429062274 EUDAMED06945429029451 EUDAMED06945429062205 EUDAMED06945429029499 EUDAMED06945429029390 EUDAMED06945429029246 EUDAMED06945429062120 EUDAMED06945429029055 EUDAMED06945429029352 EUDAMED06945429062298 EUDAMED06945429029307 EUDAMED06945429029048 EUDAMED06945429062083 EUDAMED06945429029444 EUDAMED06945429062090 EUDAMED06945429062311 EUDAMED06945429062335 EUDAMED06945429029000 EUDAMED06945429029208 EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES EUDAMEDZ12010701 FIXED SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
LED Surgical Light by Shenzhen Comen Medical Instruments Co., LTD. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06945429022384 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-06945429022384 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (51)
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