Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614502

FEI Number

3003189428

Entity Name

SEMPERMED KFT.

City/State/Country

SOPRON Gyor-Moson-Sopron, HU

Establishment Address

14 SOMFALVY U., SOPRON Gyor-Moson-Sopron 9400, HU

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Harps Europe Manufacturing (Owner Number: 8020005)

Owner / Operator Contact Address

TRIESTER BUNDESSTRASSE 26, --, WIMPASSING NIEDEROSTERREICH, AT-NOTA 2632, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191860

PMA Number

N/A

All Registered Proprietary Names

Sempermed Syntegra UV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-06-10

Official Correspondent

No official correspondent registered.

US Agent Details

Jay Mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

Harps Europe Manufacturing

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007478974	Harps Europe Manufacturing	WIMPASSING NIEDEROSTERREICH, AT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02

Similar Registrations

Registration Number	Establishment Name	Location
9610406	ANSELL (THAILAND) LTD.	THAILAND Krung Thep Maha Nakhon, TH
3012551999	ST.MARYS RUBBERS PVT LTD	Kottayam Kerala, IN
3025413681	GUILIN HUADA BIOTECHNOLOGY CO., LTD.	Guilin City Guangxi, CN
8041005	WRP ASIA PACIFIC SDN. BHD.	SALAK TINGGI, SEPANG Selangor, MY
3004122598	PRODUCTOS MEDLINE S.A. DE C.V.	NUEVO LAREDO Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614502. Last updated year: 2026. Please use registration number 9614502 when referencing this establishment in official correspondence.