Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010425916

FEI Number

3010425916

Entity Name

Terumo BCT Europe N.V.

City/State/Country

Leuven Vlaams Brabant, BE

Establishment Address

Medical Electronics, Romeinsestraat 8, Leuven Vlaams Brabant B-3001, BE

Establishment Type(s)

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

Owner / Operator

Terumo BCT, INC. (Owner Number: 9002708)

Owner / Operator Contact Address

10811 WEST COLLINS AVE., --, Lakewood, CO 80215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K991160

PMA Number

N/A

All Registered Proprietary Names

T-SEAL II Astotubes Astoline Astotherm Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSD	Device, Heat-Sealing	Hematology	Class 1	864.9750	1993-11-30
BSB	Warmer, Blood, Non-Electromagnetic Radiation	Hematology	Class 2	864.9205	2024-09-16

Official Correspondent

Corrine Lucas

US Agent Details

Corrine Lucas Business: Terumo BCT, Inc. Email: corrine.lucas@terumobct.com Phone: (720) 6106034

Related Public Records

Same Entity

Terumo BCT, 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
3001980567	TERUMO BCT, LTD	LARNE Antrim and Newtownabbey, GB
3017581284	TERUMO BCT, INC.- Littleton	Highlands Ranch, CO, US
3011720361	Terumo BCT Vietnam Co., Ltd.	Binh An commune Dong Nai, VN
1722028	Terumo BCT, Inc..	Lakewood, CO, US
1724474	Terumo BCT STERILIZATION SERVICES, Inc.	LAKEWOOD, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K090508	Belmont Instrument Corp.	THE BELMONT BUDDY LITE FLUID WARMER	2009-03-26

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9616029	Conroy Medical AB	UPPLANDS VASBY Stockholm, SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010425916. Last updated year: 2026. Please use registration number 3010425916 when referencing this establishment in official correspondence.