Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010948104

FEI Number

3010948104

Entity Name

RECO MEDIZINTECHNIK WOLFGANG RENTSCH EK

City/State/Country

Pirna Saxony, DE

Establishment Address

Altjessen 2, Pirna Saxony D-01796, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RECO MEDIZINTECHNIK Wolfgang Rentsch eK (Owner Number: 10046868)

Owner / Operator Contact Address

Altjessen 2, Pirna, DE-SN D-01796, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MPR2 logO DATALOGGER Wide range power adapter MPR1/2 EASY logO Main power adapter EASY logO Table Stand DATALOGGER Stand Holder DATALOGGER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2017-08-24
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2014-05-23

Official Correspondent

Wolfgang Rentsch

US Agent Details

Jeremy Smith Business: RAUMEDIC Inc. Email: Jeremy.Smith@raumedic.com Phone: (828) 4903262

Related Public Records

Same Entity

RECO MEDIZINTECHNIK Wolfgang Rentsch eK

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21

Similar Registrations

Registration Number	Establishment Name	Location
3006942548	RAUMEDIC - Werk Zwoenitz	Zwoenitz Saxony, DE
3004593495	Plexus Manufacturing Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
3013944123	Eurofins Infinity Laboratory Group Inc.	San Jose, CA, US
3013886523	Integra LifeSciences Switzerland Sarl	Le Locle Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010948104. Last updated year: 2026. Please use registration number 3010948104 when referencing this establishment in official correspondence.