Home›Germany›PAJUNK® GMBH MEDIZINTECHNOLOGIE

PAJUNK® GMBH MEDIZINTECHNOLOGIE

Germany · Geisingen · www.pajunk.com

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

34listed device types

Class I 9Class II 25Class III 0

plus 57 registration records and 44 510(k)

UKUnited KingdomMHRA PARD

44registered device records

Class I 4Class IIa 17Class IIb 6Class III 10System or Procedure Pack 7

BRBrazilANVISA

11registered devices

Class II 11

19 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class II 8

71 including historic records

TWTaiwanTFDA

6valid device licences

Class I 1Class II 5

SGSingaporeHSA SMDR

19device registrations

CLASS B 14CLASS D 5

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

24active ARTG entries

Class III 5IIa 13IIb 3Class Is (sterile) 3

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 1

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States57 registration records, 44 510(k), 0 PMA, 2 excluded

United Kingdom44 confirmed, 0 excluded

Brazil11 confirmed, 1 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: PAJUNK GMBH MEDIZINTECHNOLOGIE · PAJUNK MEDIZINTECHNOLOGIE GmbH

Regulatory identity

UK responsible person: Pajunk UK Medical Products Ltd

Business registration

Legal name: Pajunk GmbH Medizintechnologie
LEI: 529900PKEL9MXVMBMA20
Registration status: Active
Legal form: Gesellschaft mit beschränkter Haftung (GmbH)
Incorporated: 1978-06-13
Registered address: Karl-Hall-Strasse 1, Geisingen, 78187
Registration authority: Commercial Register, no. HRB 450245
Registry record updated: 2025-09-12

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

72006

62007

62008

12009

12011

22012

52016

32017

12018

22019

12020

12022

22023

22024

42025

FDA listed device types

showing 8 of 34

Electrosurgical, Cutting & Coagulation & Accessories 1Stimulator, Neuromuscular, External Functional 1Needle, Conduction, Anesthetic (W/Wo Introducer) 1Laparoscope, Gynecologic (And Accessories) 1Neurological Stereotaxic Instrument 1Laparoscope, General & Plastic Surgery 1Spinal Anesthesia Kit 1Catheter, Conduction, Anesthetic 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	34864	NRFit® FixoLong	Class I
UK	31245	Filter 0,2µm Filtration: 0,2µm Connectivity: ISO 80369-7 LUER	Class IIa
UK	64326	DeltaCut GUN	Class IIa
US	K243690	SonoMSK	2025-07-01
US	K243682	SonoPlex STIM; SonoPlex II	2025-06-27
US	K250774	SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture	2025-06-25
BR	80117580485	Cânulas para bloqueio de nervo periférico	Class II
BR	80117580537	Cânula para Lesão Térmica por Radiofrequência	Class II
BR	81044960007	Cânula Sonovisível Eletródica para Bloqueio e Neuromodulação de Nervos	Class II
CA	96194	DELTASEED SYSTEM	Class II
CA	96886	BOINJECT CANNULAS	Class II
CA	72850	INTRALONG SET (SPINAL ADMINISTRATION SET)	Class II