BYTEC MEDIZINTECHNIK GMBH

FDA Device Registration & Listing · Eschweiler North Rhine-Westphalia, DE · Registration 3001427085

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3001427085
FEI Number
3001427085
Entity Name
BYTEC MEDIZINTECHNIK GMBH
City/State/Country
Eschweiler North Rhine-Westphalia, DE
Establishment Address
Hermann-Hollerith-Str. 11, Eschweiler North Rhine-Westphalia 52249, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
BYTEC MEDIZINTECHNIK GMBH (Owner Number: 10023741)
Owner / Operator Contact Address
Hermann-Hollerith-Str. 11, Eschweiler, DE-NW 52249, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

EmpowerMR Injector System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZQ Injector, Contrast Medium, Automatic Cardiovascular Class 2 870.1650 2007-12-12

Official Correspondent

Paul-Willi Coenen

US Agent Details

Jonathan Watkins Business: ACIST Medical Systems, Inc. Email: jon.watkins@bracco.com Phone: (651) 8558002

Related Public Records

Same Entity

BYTEC MEDIZINTECHNIK 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 3001427085. Last updated year: 2026. Please use registration number 3001427085 when referencing this establishment in official correspondence.
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