Harps Europe Manufacturing

FDA Device Registration & Listing · WIMPASSING NIEDEROSTERREICH, AT · Registration 3007478974

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007478974
FEI Number
3007478974
Entity Name
Harps Europe Manufacturing
City/State/Country
WIMPASSING NIEDEROSTERREICH, AT
Establishment Address
TRIESTER BUNDESSTRASSE 26, WIMPASSING NIEDEROSTERREICH 2632, AT
Establishment Type(s)
Manufacture 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
N
Expiration Date (Year)
2026
510(k) Number
K013560
PMA Number
N/A

All Registered Proprietary Names

Syntegra PreCision Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves Syntegra Green Sempermed Syntegra UV Henry Schein Criterion PI Dealmed Pivetal Latex Surgical

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 2017-11-03
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2013-02-14
LZC Medical Glove, Specialty General Hospital Class 1 880.6250 2025-12-04
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2025-12-04
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2020-06-10
KGO Surgeon'S Gloves General, Plastic Surgery Class 1 878.4460 2007-12-06

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
9614502 SEMPERMED KFT. SOPRON Gyor-Moson-Sopron, HU

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 3007478974. Last updated year: 2026. Please use registration number 3007478974 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.