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Light sources with LED for ICG

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 5165002Model 10000201439

by Richard Wolf GmbH

Identity

Trade Name
ENDOLIGHT FDA UDI
Generic Name
Endoscopic light source unit, line-powered FDA UDI
Device Name
Light sources with LED for ICG EUDAMED
LIGHT SOURCE LED GREEN For fluorescence imaging with ICG dye, With 2 LED light sources, Quiet operation, Dialog function, compatible with core nova, WOLF light-cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 300x160x424mm FDA UDI
Model / Reference
10000201439 EUDAMED
5165002 EUDAMEDFDA UDI
Description
LIGHT SOURCE LED GREEN For fluorescence imaging with ICG dye, With 2 LED light sources, Quiet operation, Dialog function, compatible with core nova, WOLF light-cable connection, 6500K, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 300x160x424mm FDA UDI

Identifiers

Catalog Number
5165002 FDA UDI
Primary DI / UDI-DI
04055207065631 EUDAMEDFDA UDI
Basic UDI-DI
405520725102019-0028045FB EUDAMED
Direct Marketing DI
04055207065631 EUDAMED
FDA Product Code
NTN FDA UDI
EMDN Code
Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
GMDN Term
Endoscopic light source unit, line-powered FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Market of Registration
Germany 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Light sources with LED for ICG by Richard Wolf GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Richard Wolf GmbH
EUDAMED SRN
DE-MF-000007048

Sources (2)

  • EUDAMED 6e8aadb9-7ad1-45f8-a9ff-bc648de9b9f2 61 fields · synced Jun 19, 2026
  • FDA UDI 8a15bf75-00a5-45d3-bbbe-7e7ee1993817 35 fields · synced May 30, 2026