Is this your brand? Sign in to claim ownership.
Sign in to claim this brandPajunk GmbH Medizintechnologie
US
Last updated May 24, 2026
What Pajunk GmbH Medizintechnologie makes
Pajunk GmbH Medizintechnologie manufactures single-use spinal and peripheral anaesthesia needles, including nerve-locating and sharp nerve-block variants, as well as non-medicated epidural anaesthesia sets. Their portfolio also includes reusable endoscopic electrosurgical handpieces and electrodes, alongside percutaneous radio-frequency ablation probe cannulas. The company produces peripheral anaesthesia catheter sets and non-threaded epidural needles, designed for procedural and surgical applications.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory standards for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Pajunk GmbH Medizintechnologie primarily manufacture?
Pajunk GmbH Medizintechnologie specializes in anaesthesia-related devices, including single-use spinal and peripheral anaesthesia needles (such as nerve-locating and sharp nerve-block variants), non-medicated epidural anaesthesia sets, and peripheral anaesthesia catheter sets. Their portfolio also includes reusable endoscopic electrosurgical handpieces/electrodes and single-use percutaneous radio-frequency ablation probe cannulas. These devices are designed for procedural and surgical applications, particularly in pain management and regional anaesthesia.
Where is Pajunk GmbH Medizintechnologie based, and how does this affect its regulatory compliance?
Pajunk GmbH Medizintechnologie operates from the United States, meaning its devices must comply with FDA regulations. The company’s products fall under FDA’s Class I and Class II classifications, which determine the regulatory scrutiny and requirements for premarket submission, labeling, and post-market surveillance. Compliance with U.S. standards ensures their devices meet safety, performance, and quality benchmarks for use in American healthcare settings.
Are Pajunk GmbH Medizintechnologie’s devices listed in any regulatory databases, and why does this matter?
Yes, Pajunk GmbH Medizintechnologie’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This matters because UDI ensures traceability, transparency, and efficient tracking of medical devices throughout their lifecycle—from manufacturing to patient use. It helps healthcare providers verify device details, reduces medical errors, and supports regulatory oversight by linking devices to their specific design, manufacturing, and compliance histories.
How are Pajunk GmbH Medizintechnologie’s devices classified under FDA regulations, and what does this classification imply?
Pajunk GmbH Medizintechnologie’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls (e.g., good manufacturing practices) for compliance. Class II devices involve moderate risk and may require additional controls like performance standards or post-market surveillance to ensure safety and effectiveness. The classification determines the regulatory pathway, labeling requirements, and level of scrutiny each device undergoes before and after market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pajunk-usa.com
- —
- —
- [email protected]
- Phone
- +1 770-493-6832
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 317654283
Catalogue (2005)
Page 3 of 41| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Uniplex® Nanoline | 001156-80 | FDA UDI | Class II | Active |
| Sprotte® | 221151-30C | FDA UDI | Class II | Unknown |
| TuohySono | 1085-4K090 | FDA UDI | Class II | Active |
| Faceshield | Z9070013 | FDA UDI | Class I | Unknown |
| Sprotte® | 321151-31A | FDA UDI | Class II | Unknown |
| Sprotte® | 051151-30C | FDA UDI | Class II | Unknown |
| Tl | 001155-12 | FDA UDI | Class II | Active |
| Sonoplex | 001187-85 | FDA UDI | Class II | Unknown |
| EpiLong Soft Sono | 0631187-51 | FDA UDI | Class II | Unknown |
| E-Cath Tsui | 251285-40E | FDA UDI | Class II | Unknown |
| SonoBlock | 001180-81 | FDA UDI | Class II | Active |
| Tuohy | 1150-6G091 | FDA UDI | Class II | Unknown |
| Epilong | 0431157-48 | FDA UDI | Class II | Active |
| Catheter | 041163-37R | FDA UDI | Class II | Unknown |
| Exchangeable suction-Irrigation tube | 1298-00-05OL | FDA UDI | Class II | Unknown |
| FlowSys Tube | 1298-00-06 | FDA UDI | Class II | Unknown |
| FixoCath | 001151-37Z | FDA UDI | Class II | Unknown |
| TuohySono | 1085-4E070 | FDA UDI | Class II | Unknown |
| SonoPlex® II Facet NRFit | 001265-70 | FDA UDI | Class II | Active |
| SonoPlex II Facet S | 001287-70 | FDA UDI | Class II | Unknown |
| IntroDucer | 021151-30M | FDA UDI | Class I | Unknown |
| Epispin | 0021352-18 | FDA UDI | Class II | Unknown |
| E-Cath® NRFit Tsui® | 241265-40E | FDA UDI | Class II | Unknown |
| Veress Needle | 1206-21120 | FDA UDI | Class II | Unknown |
| UniMSK | 1192-4E150 | FDA UDI | Class II | Unknown |
| InfiltraLong 600 | 001158-20B | FDA UDI | Class II | Active |
| Sonolong Echo | 561185-31A | FDA UDI | Class II | Unknown |
| Introducer | 021163-30L | FDA UDI | Class I | Unknown |
| Tuohy | 1085-4K150 | FDA UDI | Class II | Unknown |
| Sonolong | 501185-31I | FDA UDI | Class II | Unknown |
| Multistim Vario | 1151-94-02 | FDA UDI | Class II | Unknown |
| EpiLong | 0331153-48 | FDA UDI | Class II | Unknown |
| Fixocath | 001151-37Z | FDA UDI | Class II | Active |
| Uniplex® Nanoline | 001156-71 | FDA UDI | Class II | Active |
| Tuohy NRFit | 1166-6M091 | FDA UDI | Class II | Unknown |
| Tuohy | 1166-6G091 | FDA UDI | Class II | Unknown |
| Sprotte® | 001163-30D | FDA UDI | Class II | Unknown |
| Stimulong Sono | 531157-32A | FDA UDI | Class II | Unknown |
| Verschlusskappe | 001163-38S | FDA UDI | Class II | Active |
| Tuohy | 1166-4O110 | FDA UDI | Class II | Unknown |
| Sonolong | 501185-31I | FDA UDI | Class II | Unknown |
| Tuohy | 1150-4O150 | FDA UDI | Class II | Unknown |
| SonoBlock | 001180-72 | FDA UDI | Class II | Unknown |
| VPC 10ml | 0001151-49 | FDA UDI | Class II | Unknown |
| Tuohy | 1150-4M090 | FDA UDI | Class II | Unknown |
| Sonolong Echo | 521185-31A | FDA UDI | Class II | Unknown |
| UniPlex | 001153-70 | FDA UDI | Class II | Unknown |
| Uni Msk | 1192-4E120 | FDA UDI | Class II | Unknown |
| Tuohy Sono | 1085-4F090 | FDA UDI | Class II | Unknown |
| EpiSpin Lock | 0011351-18 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Pajunk Gmbh Medizintechnologie GEISINGEN Baden-Wurttemberg · DE FEI 3002807847