Miltenyi Biotec B. V. & Co. KG

FDA Device Registration & Listing · Bergisch Gladbach North Rhine-Westphalia, DE · Registration 3005290010

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
3005290010
FEI Number
3004112148
Entity Name
Miltenyi Biotec B. V. & Co. KG
City/State/Country
Bergisch Gladbach North Rhine-Westphalia, DE
Establishment Address
Friedrich-Ebert-Strasse 68, Bergisch Gladbach North Rhine-Westphalia D-51429, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Miltenyi Biotec/Dinsmore (Owner Number: 10031807)
Owner / Operator Contact Address
1 1st Ave., Bldg 34, Suite 401, Charlestown, MA 02129, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK090020
PMA Number
N/A

All Registered Proprietary Names

CD34 Separation System ASR antibodies Freezing bags

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVG Magnetic Cell Selection System For Cd34+ Cells From Hpc-Apheresis Used In Treatment Of Acute Myeloid Leukemia (Aml) Unknown Class f N/A 2015-03-25
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2021-03-18
LPZ Container, Frozen Donor Tissue Storage Unknown Class U N/A 2010-03-10

Official Correspondent

Jonathan Dinsmore

US Agent Details

Jonathan Dinsmore Business: Miltenyi Biotec Email: jonathand@miltenyi.com Phone: (617) 4488043

Related Public Records

Same Entity

Miltenyi Biotec/Dinsmore
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3008264130 Miltenyi Biotec B. V. & Co. KG Branch Teterow Teterow Mecklenburg-Western Pomerania, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005290010. Last updated year: 2026. Please use registration number 3005290010 when referencing this establishment in official correspondence.
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