Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027305794

FEI Number

3027305794

Entity Name

KM HEALTHCARE

City/State/Country

Cheorwon-gun, Gangwon-do, KR

Establishment Address

31-51, Geumhak-ro, Donsong-eup,, Cheorwon-gun, Gangwon-do 24025, KR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KM Healthcare (Owner Number: 10087950)

Owner / Operator Contact Address

144, Donggureung-ro 395 beon-gil, Guri-si, Gyeonggi-do, KR-NOTA 11905, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SCOPEYE 3D MICROVISION (SE-MV) Geniant Cranial (Navigated Neurosurgical Positioning Robot)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EPT	Microscope, Surgical	General, Plastic Surgery	Class 1	878.4700	2026-01-07
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-02-12

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

KM Healthcare

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06
K031454	Biomet, Inc.	ACUMEN SURGICAL NAVIGATION SYSTEM	2004-07-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

Similar Registrations

Registration Number	Establishment Name	Location
3014214496	SOMETECH GLOBAL CO., LTD	Guro-gu Seoul, KR
3009057691	LIFE SCIENCE LOGISTICS, LLC	Brownsburg, IN, US
3016527960	Sony Global Manufacturing & Operations Corporation Kohda Site	Nukata-gun Aichi, JP
1000204638	LEICA INSTRUMENTS (SINGAPORE) PTE LTD.	SINGAPORE South West, SG
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027305794. Last updated year: 2026. Please use registration number 3027305794 when referencing this establishment in official correspondence.