4K UHD Laparoscope

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 4K1030LModel 4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR)，4K5530L(&LR)，4K5545L(&LR)

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name: 4K UHD Laparoscope EUDAMEDFDA UDI
Generic Name: Rigid optical laparoscope FDA UDI
Device Name: 4K UHD Laparoscope EUDAMED
Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter. FDA UDI
Model / Reference: 4K5500(&R),4K5530(&R),4K5545(&R),4K1000(&R),4K1030(&R),4K1045(&R),4K1000L(&LR),4K1030L(&LR),4K1045L(&LR),4K5500L(&LR)，4K5530L(&LR)，4K5545L(&LR) EUDAMED
4K1030L EUDAMEDFDA UDI
Description: Scivita 4KINSIGHT ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging. The Scivita 4KINSIGHT ICG Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, including but not limited the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), colon, liver and uterus, using near infrared imaging. Fluorescence imaging of biliary ducts, colon, liver and uterus, with the Scivita 4KINSIGHT ICG Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for visualization of biliary duct, colon, liver and uterus. 4K UHD Laparoscope is intended to be used for imaging and observation during endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.The product is composed of eyepiece, lens body, optic fiber interface and adapter. FDA UDI

Identifiers

Primary DI / UDI-DI: 06971381251395 EUDAMEDFDA UDI
Basic UDI-DI: 697138125004A88 EUDAMED
Direct Marketing DI: 06971381251395 EUDAMED
510(k) Number: K221252 FDA UDI
FDA Product Code: GCJ FDA UDI
IZI FDA UDI
EMDN Code: Z12029009 LAPAROSCOPES EUDAMED
GMDN Term: Rigid optical laparoscope FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
892.1600 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

4K UHD Laparoscope by Scivita Medical Technology Co., Ltd. — Class IIa — 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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	697138125004A88	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Scivita Medical Technology Co., Ltd.
EUDAMED SRN: CN-MF-000010305
Authorised Representative: Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

EUDAMED e58ea027-31f3-4c4c-870b-f05abd440d62 61 fields · synced Jun 19, 2026
FDA UDI 722ed3f1-49bb-4c64-b15c-10f7f793a8cc 35 fields · synced May 30, 2026