Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017865161

FEI Number

3017865161

Entity Name

PEMAX KUNSTSTOFF GMBH

City/State/Country

Stuttgart Baden-Wurttemberg, DE

Establishment Address

Curiestr. 2, Stuttgart Baden-Wurttemberg 70563, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pemax Kunststoff GmbH (Owner Number: 10079845)

Owner / Operator Contact Address

Curiestr. 2, Stuttgart, DE-BW 70563, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Robotic scope sterile drape No. 12364 PC3-VB10-3 6 clip Drape VB10-RC Remote Control Unit Drap Set HMD cover sterile No. 12364 Robotic scope sterile drape No. 13928 VB10-SC Smart Control Drape PC2-SD-3 PC3-SCSA-3 Wound irrigation cannula BCXXXX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-12-29
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2024-02-22

Official Correspondent

Ulrich Bahr

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Pemax Kunststoff GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017865161. Last updated year: 2026. Please use registration number 3017865161 when referencing this establishment in official correspondence.