Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027153085

FEI Number

3027153085

Entity Name

Mitsubishi Chemical Advanced Materials Kft.

City/State/Country

Szigetszentmiklos Budapest, HU

Establishment Address

Szigetszentmiklos Leshegy u.30., Szigetszentmiklos Budapest 2310, HU

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MCAM Hungary Kft. (Owner Number: 10087716)

Owner / Operator Contact Address

Szigetszentmiklos Leshegy u.30., Szigetszentmiklos, HU-BU 2310, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Compound W Nitro freeze Skin Tag Remover COMPOUND W NITROFREEZE + GELPADS COMPOUND W NITROFREEZE 10ML + GELPADS COMPOUND W NITROFREEZE FIRST AID COMPOUND W NITROFREEZE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ORE	N/A	N/A	Class N/A	N/A	2025-01-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2025-01-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2023-03-30

Official Correspondent

Zsolt Mihaly

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

MCAM Hungary Kft.

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027153085. Last updated year: 2026. Please use registration number 3027153085 when referencing this establishment in official correspondence.