Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002806503

FEI Number

3002806503

Entity Name

Baxalta Belgium Manufacturing SA

City/State/Country

Lessines Hainaut, BE

Establishment Address

Boulevard Rene Branquart 80, Lessines Hainaut 7860, BE

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

N/A

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
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2016-07-26

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
3015054258	SHIRE HUMAN GENETIC THERAPIES, INC.	Thousand Oaks, CA, US
9616848	Takeda Manufacturing Austria AG	VIENNA Wien, AT
3016938816	Takeda Pharmaceuticals U.S.A., Inc.	Lexington, MA, US
3009340644	SHIRE HUMAN GENETIC THERAPIES, INC.	Lexington, MA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002806503. Last updated year: 2026. Please use registration number 3002806503 when referencing this establishment in official correspondence.