FDA Registration Active 🇩🇪 Germany

PAJUNK GMBH MEDIZINTECHNOLOGIE

Reg #: 9611612 · FEI: 3002807847 · Expires 2026
Products
34
Proprietary Names
233
Establishment Types
6
Classifications
34

Registration Details

Registration Name
PAJUNK GMBH MEDIZINTECHNOLOGIE
Registration Number
9611612
FEI Number
3002807847
Status
Active
Expiry Year
2026
Initial Importer
No
Address
KARL-HALL-STRASSE 01
City
GEISINGEN Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K243525

Owner / Operator

Firm Name
PAJUNK GmbH Medizintechnologie
Operator Number
8010639
Address
Karl-Hall-Strasse 1
City
Geisingen
State
Baden-Wurttemberg
Postal Code
78187
Country
DE

US Agent

Business Name
PAJUNK MEDICAL SYSTEMS
Contact Name
Marco Wohnig
Address
4575 Marconi Dr.
City
Alpharetta
State
GA
ZIP
30005
Country
US
Phone
770 7572449

Products

Device Name Product Code
System, Applicator, Radionuclide, Manual IWJ
Hysteroscope (And Accessories) HIH
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Custom Anesthesia Tray OGD
Instrument, Surgical, Disposable KDC
Instrument, Biopsy KNW
Guide, Needle, Surgical GDF
Filter, Conduction, Anesthetic BSN
Anesthesia Conduction Kit CAZ
Tape And Bandage, Adhesive KGX
Laparoscope, General & Plastic Surgery GCJ
Catheter, Conduction, Anesthetic BSO
Handle, Scalpel GDZ
Manometer, Spinal-Fluid FMJ
Biopsy Needle FCG
Cannula, Ophthalmic HMX
Accessories, Pump, Infusion MRZ
Stimulator, Neuromuscular, External Functional GZI
Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
Stimulator, Muscle, Powered IPF
Device, Biofeedback HCC
Laparoscope, Gynecologic (And Accessories) HET
Generator, Lesion, Radiofrequency GXD
Probe, Radiofrequency Lesion GXI
Electrosurgical, Cutting & Coagulation & Accessories GEI
Neurological Stereotaxic Instrument HAW
Instrument, Manual, Surgical, General Use MDM
Ureteroscope And Accessories, Flexible/Rigid FGB
Syringe, Periodontic, Endodontic, Irrigating EIC
Epidural Anesthesia Kit OGE
Device, Percutaneous, Biopsy MJG
Stimulator, Nerve, Battery-Powered BXN
Introducer, Catheter DYB
Spinal Anesthesia Kit OFU

Proprietary Names

DeltaFix Stopcock Accessory W7120948 SonoTAP SonoTAP NRFit SonoTAP II SonoTAP II NRFit TuohySono SonoMSK SonoPlex II Facet SonoPlex II SonoPlex STIM SonoPlex II Facet S NRFit® SonoPlex II Facet S SonoPlex II Facet NRFit® SPROTTE® NRFit kit EpiLong Soft NRFit Injection tube, anesthetic agent DeltaCut DeltaCut Biopsy Coaxial sleeve TunnEler 235 Filter NRFit EpiLong EpiLong Paed EpiLong Echo Paed FixoLong TrocaObt PYRAMID Hasson cone TrocaObt PROTECT EcoBalloon TrocaPort TrocaObt HASSON EcoBalloon OBT RA EcoBalloon OBT DIL TrocaObt SHIELD EcoBalloon OBT RA-S EcoBalloon OBT PROTECT TrocaTec MAN TrocaObt CONE EcoBalloon TrocaTec MAN TrocaPort TOP TrocaPort SLEEVE TrocaTube EcoBalloon OBT SB TrocaTec AUTO EcoBalloon TrocaTec AUTO TrocaPort Combination handle FlowSys FlowSys Ergo HF ErgoFlex FlowSys Eco+ HF FlowSys HF FlowSys Pistol FlowSys Tube FlowSys Eco HF ErgoGrip TipHandle Free-moving handle TipRatchet Handle with ratchet BigFlow FlowSys HF Duo FlowSys Duo Handle with tilting EpiLong I EpiLong Soft Cath EpiLong Cath MiniFilter 0,2µm LOR NRFit 10ml, Slip EpiLong II EpiLong Soft LOR 10ml EpiLong NRFit Cath EpiLong Tuohy EpiLong NRFit Rundfilter 0,2µm SonoCut NerveGuard NerveGuard NRFit Spinal Manometer NRFit Manometer Extension Spinal Manometer ChibaSono MonoBalloon RA-S VarioBalloon RA EcoBalloonDuo DIL + RA VarioBalloon RA-S EcoBalloonDuo DIL + SB VarioBalloon URO VarioBalloon SB EcoBalloon DIL EcoBalloon RA MonoBalloon RA EcoBalloon DIL-XL MonoBalloon DIL-BI EcoBalloon URO-S EcoBalloon SB EcoBalloon DIL-BI MonoBalloon URO-S VarioBalloon URO-S MonoBalloon DIL MonoBalloon SB MonoBalloonDuo EcoBalloonDuo EcoBalloon RA-S MonoBalloon DIL-XL MonoBalloon URO VPC NRFit 10ml VPC 10ml Tuohy NRFit E-Cath® Tsui® E-Cath® II Tsui® E-Cath® II Plus Tsui® E-Cath® PLUS NRFit E-Cath® PLUS Tsui® E-Cath® NRFit Tsui® SonoBlock SonoBlock II Facet SonoBlock II Facet NRFit SonoBlock II Facet S SonoEye PlexoLong Cath 20Gx50cm StimuLong Sono II PlexoLong Sono NanoLine® SonoLong SoftSecure SonoLong Echo SonoLong Sono NanoLine® StimuLong Sono SonoLong Echo NanoLine® PlexoLong NanoLine® NRFit StimuLong Sono NRFit SonoLong Mini SonoLong Curl Echo PlexoLong Cath 20Gx50cm PlexoLong NanoLine® StimuLong NanoLine® MultiSet UniPlex® NanoLine® InfiltraLong 500 InfiltraLong 600 InfiltraLong 900 InfiltraLong 900T InfiltraLong 700T InfiltraLong 420T InfiltraLong 420 InfiltraLong Sono InfiltraLong 900T InfiltraLong 600T InfiltraLong 700 InfiltraLong 500T Stim2Go PTC 18G x 150mm PTC 16G x 150mm Puncture cannula PTC 16G x 200mm PTC 20G x 150mm PTC 21G x 200mm PTC 18G x 200mm Disposable Veress Cutting cannula Insufflation cannula RFTL RGN RFTL Sono TL Chiba Tuohy CauDal NRFit CauDal CauDal Sono Quincke NRFit SPROTTE® NRFit FlowTube HF RET FlowHandle HF Right-Angle Electrode EcoHF-Grip FlowTube HF FixoCath Customised Convenience Kit EpiSpin Safety NRFit ClampingAdapter EpiSpin Lock Soft EpiSpin II Safety EpiSpin Lock SPROTTE® STANDARD NRFit® SPROTTE® STANDARD SPROTTE® STANDARD 2.G Disposable Biopsy Initial cannula Injection Cannula Special puncture IntroDucer IntroDucer NRFit FlowSys FLUSH ErgoTop ErgoNeedle Clamp w / DeBakey teeth ErgoForceps ErgoClamp ErgoScissors VARIOJECT VARIOSAFE PLURAJECT UNIJECT Radiofrequency probe, reusable, disposable FlowTube HF-C Handle HF-C FlowTube HF-C RET Epidural anesthesia kit MonoTip TipRod Ergo EcoHF-Tip P ErgoTube TipTube TipRod PrimoCut Core-Cut Biopsy system Core-Cut NerveStim Pure MULTISTIM ECO VascularSono Sono MSK E-Cath STIM Tsui E-Cath STIM Plus Tsui Locking cap NRFit RF Lesion Generator ClampingAdapter white ClampingAdapter NRFit yellow ClampingAdapter yellow SPROTTE NRFit Kit Spinal anesthesia kit Disposable Biopsy Needle 2.1 x 190 mm for Leksell Frame Disposable Pre-calibrated Biopsy Needle 2.1 x 257 mm

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility