FRESENIUS KABI AB

FDA Device Registration & Listing · Uppsala, SE · Registration 3002631703

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
3002631703
FEI Number
3002631703
Entity Name
FRESENIUS KABI AB
City/State/Country
Uppsala, SE
Establishment Address
Fresenius Kabi AB, Rapsgatan 7, Uppsala 75174, SE
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Fresenius Kabi AB (Owner Number: 10038639)
Owner / Operator Contact Address
Fresenius Kabi AB, Rapsgatan 7, Uppsala, SE-C 75174, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Fresenius Kabi AB, Uppsala, Sweden Rotaglide Lubricant

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MCW Catheter, Peripheral, Atherectomy Cardiovascular Class 2 870.4875 2011-10-31
MCX Catheter, Coronary, Atherectomy Unknown Class 3 N/A 2023-11-06

Official Correspondent

Carolina Sjogren

US Agent Details

Aparna Dagar Business: Fresenius Kabi Email: aparna.dagar@fresenius-kabi.com Phone: (847) 2127847

Related Public Records

Same Entity

Fresenius Kabi AB
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 3002631703. Last updated year: 2026. Please use registration number 3002631703 when referencing this establishment in official correspondence.
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