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SunLED 4C

EUDAMED

Class I (EU MDR)

Ref SunLED 4CModel SunLED 1

by Mediland Medical Equipment Enterprise Corporation Company

Identity

Trade Name
SunLED 4C EUDAMED
Device Name
SunLED Series Surgical Light EUDAMED
Model / Reference
SunLED 1 EUDAMED
SunLED 4C EUDAMED

Identifiers

Primary DI / UDI-DI
06974724356412 EUDAMED
Basic UDI-DI
697472435SunLEDHC EUDAMED
EMDN Code
Z12010701 FIXED SCIALYTIC LAMPS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands 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

Category: Operating room light system

SunLED 4C by Mediland Medical Equipment Enterprise Corporation Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Operating room light system.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000014619
Authorised Representative
Luana Med. B.V. NL-AR-000002750

Sources (1)

  • EUDAMED 66545ae1-d9fc-4348-bca1-771a4278e16b 61 fields · synced Jun 17, 2026