Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008833258

FEI Number

3008833258

Entity Name

TROMP MEDICAL BV

City/State/Country

Castricum Noord-Holland, NL

Establishment Address

Oude Haarlemmerweg 75, Castricum Noord-Holland 1901 ND, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Tromp Medical (Owner Number: 10092743)

Owner / Operator Contact Address

Oude Haarlemmerweg 75, Castricum, NL-NH 1901 ND, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P080003

All Registered Proprietary Names

Hologic Mammo 113T tube Hologic Selenia Dimensions Mammography Hologic Selenia Dimensions 3D Mammo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2025-02-25
MUE	Full Field Digital, System, X-Ray, Mammographic	Radiology	Class 2	892.1715	2025-07-25
OTE	Digital Breast Tomosynthesis	Unknown	Class 3	N/A	2025-02-13

Official Correspondent

Roderik Wondergem

US Agent Details

Grace Lyon Email: grace.lyon@blockimaging.com Phone: (517) 6688800

Related Public Records

Same Entity

Tromp Medical

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-2219-2025	FUJIFILM Healthcare Americas Corporation	3	ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

Similar Registrations

Registration Number	Establishment Name	Location
3042255107	Micro X-ray Technology (Suzhou) Co., Ltd	suzhou Jiangsu, CN
3014205374	Varex Imaging Equipment (China) Co., LTD	Wuxi Jiangsu, CN
3006789424	Hangzhou Kailong Medical Instruments Co., Ltd.	Hangzhou Zhejiang, CN
3000275399	Siemens Healthineers AG	RUDOLSTADT Thuringia, DE
3017616637	MINGWEI MEDICAL TECHNOLOGY(SUZHOU) CO.,LTD	Suzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008833258. Last updated year: 2026. Please use registration number 3008833258 when referencing this establishment in official correspondence.