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
- [email protected]
- Phone
- 770 7572449
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2004-04-02 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2022-01-19 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2025-06-18 |
| Custom Anesthesia Tray | OGD | Class 2 | Anesthesiology | No | 2016-11-07 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2024-03-13 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2014-08-27 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2016-09-09 |
| Filter, Conduction, Anesthetic | BSN | Class 2 | Anesthesiology | No | 2020-07-20 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2014-08-27 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2019-07-02 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2014-08-27 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2009-04-17 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-11-03 |
| Manometer, Spinal-Fluid | FMJ | Class 2 | General Hospital | No | 2020-07-02 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2014-08-28 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1986-05-06 |
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2008-07-08 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2024-01-10 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2024-01-10 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2024-01-10 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2024-01-10 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2006-12-19 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2006-09-20 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2006-09-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2014-08-28 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2006-09-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2001-06-07 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2020-09-14 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2007-07-16 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2017-12-05 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2008-05-14 |
| Stimulator, Nerve, Battery-Powered | BXN | Class 2 | Anesthesiology | No | 2020-11-10 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2012-02-10 |
| Spinal Anesthesia Kit | OFU | Class 2 | Anesthesiology | No | 2016-10-24 |
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