Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616848

FEI Number

3002669612

Entity Name

Takeda Manufacturing Austria AG

City/State/Country

VIENNA Wien, AT

Establishment Address

INDUSTRIESTRASSE 67, VIENNA Wien A1220, AT

Establishment Type(s)

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

Owner / Operator

Takeda Pharmaceuticals U.S.A., Inc. (Owner Number: 10049748)

Owner / Operator Contact Address

500 Kendall St., Cambridge, MA 02142, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071459

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2016-08-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-08-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2016-08-09

Official Correspondent

Shilpa Gampa

US Agent Details

Shilpa Gampa Business: FREYR INC Email: usagent@freyrsolutions.com Phone: (760) 5834401

Related Public Records

Same Entity

Takeda Pharmaceuticals U.S.A., Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016418550	Takeda Pharmaceuticals U.S.A., Inc.	Cambridge, MA, US
3002806503	Baxalta Belgium Manufacturing SA	Lessines Hainaut, BE
3015054258	SHIRE HUMAN GENETIC THERAPIES, INC.	Thousand Oaks, CA, US
3016938816	Takeda Pharmaceuticals U.S.A., Inc.	Lexington, MA, US
3009340644	SHIRE HUMAN GENETIC THERAPIES, INC.	Lexington, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

Similar Registrations

Registration Number	Establishment Name	Location
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3006153342	Omnicell S.R.L.	TRIESTE, IT
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US
2523676	B. BRAUN US DEVICE MANUFACTURING LLC	ALLENTOWN, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616848. Last updated year: 2026. Please use registration number 9616848 when referencing this establishment in official correspondence.