Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005060446

FEI Number

3005060446

Entity Name

CARL ZEISS CMP GMBH

City/State/Country

Goettingen Lower Saxony, DE

Establishment Address

Koenigsallee 9-21, Goettingen Lower Saxony 37081, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Carl Zeiss CMP GmbH (Owner Number: 10091355)

Owner / Operator Contact Address

Koenigsallee 9-21, Göttingen, DE-NI 37081, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VENTANA® DP 200 slide scanner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PSY	Whole Slide Imaging System	Pathology	Class 2	864.3700	2024-12-12

Official Correspondent

Johannes Pfingstmann

US Agent Details

Brian Frazier Business: Roche Diagnostics Operations Inc Email: brian.frazier@roche.com Phone: (317) 5214603

Related Public Records

Same Entity

Carl Zeiss CMP GmbH

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
K243871	Philips Medical Systems Nederland B.V.	Philips IntelliSite Pathology Solution 5.1	2025-03-06

Similar Registrations

Registration Number	Establishment Name	Location
3012563754	Philips Medical Systems Nederland B.V.	Best Noord-Brabant, NL
3008491142	FUJIFILM Healthcare Americas Corporation	Lexington, MA, US
3003584784	SHANDON DIAGNOSTICS LIMITED	RUNCORN Cheshire East, GB
9614683	HAMAMATSU PHOTONICS K.K., SYSTEMS DIVISION	HAMAMATSU CITY Shizuoka, JP
1000181154	BARCO S.R.L.	Saronno Varese, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005060446. Last updated year: 2026. Please use registration number 3005060446 when referencing this establishment in official correspondence.