Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014724561

FEI Number

3014724561

Entity Name

EMD ENDOSZKOP MUSZER GYARTO ES KERESKEDELMI KFT.

City/State/Country

Debrecen Hajdu-Bihar, HU

Establishment Address

Bartok Bela Str. 113/B, Debrecen Hajdu-Bihar 4031, HU

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft. (Owner Number: 10090499)

Owner / Operator Contact Address

Bartok Bela Str. 113/B, Debrecen, HU-HB 4031, HU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213228

PMA Number

N/A

All Registered Proprietary Names

NeuroLine Disposable Cranial Perforator with Hudson-end

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HBF	Drills, Burrs, Trephines & Accessories (Compound, Powered)	Neurology	Class 2	882.4305	2024-04-05

Official Correspondent

Gergo Ujvari

US Agent Details

Miklos Varga Email: mikifolda@gmail.com Phone: (954) 2747654

Related Public Records

Same Entity

EMD Endoszkop Muszer Gyarto es Kereskedelmi Kft.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014724561. Last updated year: 2026. Please use registration number 3014724561 when referencing this establishment in official correspondence.