Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015351183

FEI Number

3015351183

Entity Name

RECENSMEDICAL INC.

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

3F, 64-10, Dongtangiheung-ro, Dongtan-gu, Hwaseong-si, Gyeonggi-do Republic of Korea, Hwaseong-si Gyeonggi 18468, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Recensmedical Inc. (Owner Number: 10082084)

Owner / Operator Contact Address

#908, SK V1 center, 830 Dongtansunhwan-daero, Hwaseong-si, Gyeonggi-do, Republic of Korea, Hwaseong-si, KR-41 18468, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K253348

PMA Number

N/A

All Registered Proprietary Names

TargetCool TargetCool-e

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MLY	Vapocoolant Device	Unknown	Class U	N/A	2025-12-15
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-12-15
MLY	Vapocoolant Device	Unknown	Class U	N/A	2025-12-15
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-12-15

Official Correspondent

No official correspondent registered.

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

Recensmedical Inc.

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
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16

Similar Registrations

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3012448339	STERI-TEK	Fremont, CA, US
3021853802	VAPOCOOLSHOT, INC	Boca Raton, FL, US
3015177815	Hubot, Inc.	South Bend, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015351183. Last updated year: 2026. Please use registration number 3015351183 when referencing this establishment in official correspondence.