EUROPEAN MEDICAL CONTRACT MFG.

FDA Device Registration & Listing · NIJMEGEN Gelderland, NL · Registration 9614559

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
9614559
FEI Number
3002806942
Entity Name
EUROPEAN MEDICAL CONTRACT MFG.
City/State/Country
NIJMEGEN Gelderland, NL
Establishment Address
MIDDENKAMPWEG 17, NIJMEGEN Gelderland 6545 CH, NL
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
European Medical Contract Manufacturing (E.M.C.M.) B.V. (Owner Number: 9039600)
Owner / Operator Contact Address
MIDDENKAMPWEG 17, --, NIJMEGEN, NL-GE CH 6545, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BioXmark

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QUV Phase-Changing Fiducial Marker For Radiation Therapy Radiology Class 2 892.5727 2023-12-13

Official Correspondent

Mark Saris

US Agent Details

Kela Veshi Business: Kelaveshi Email: kelaveshi@yahoo.com Phone: (301) 7920964

Related Public Records

Same Entity

European Medical Contract Manufacturing (E.M.C.M.) B.V.
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 9614559. Last updated year: 2026. Please use registration number 9614559 when referencing this establishment in official correspondence.
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