Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020981987

FEI Number

3020981987

Entity Name

TFB MANUFACTURING SRL

City/State/Country

La Lima, Guadalupe Cartago, CR

Establishment Address

Calle 58, Zona Franca La Lima, Planta de Terumo BCT - Calle Duan y Avenida Turrialba, La Lima, Guadalupe Cartago 30106, CR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered Proprietary Names

Trima Accel LRS Platelet, Plasma Set (ISBT) Trima Accel System - Quiet Pumps Spectra Optia Spectra Optia Collet Set Spectra Optia - Modified Spectra Optia Exchange Set Spectra Optia Single Needle TPE Spectra Optia Exchange Set Spectra Optia Single-Needle Connector Spectra Optia Spectra Optia IDL Set Spectra Optia Collect Set Spectra Optia Exchange Set Spectra Optia Apheresis System Spectra Optia Collect Set Trima Accel Platelet + Sampler, Plasma, Auto RBC Set (ISBT) Trima Accel Platelet, Plasma, Auto RBC Set (ISBT) RBCX Exchange Set Spectra Optia Exchange Set Spectra Dual Needle ISBT Tubing Kit, Waste Bag Trima Accel System Trima LRS Platelet, Plasma, RBC Autopas Set Trima Accel Platelet, Plasma Set Trima Accel Platelet + Sampler, Plasma, RBC Set Spectra Optia Apheresis System Spectra Optia BMP Set with Source Plasma Bag

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-08-18
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2017-08-14
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-03-24
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2017-08-10
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2014-01-14
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2015-10-22
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-03-11
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-08-18
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2016-08-18
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-08-18
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2013-10-28
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-09-28
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-03-11

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
3010425916	Terumo BCT Europe N.V.	Leuven Vlaams Brabant, BE
3011720361	Terumo BCT Vietnam Co., Ltd.	Binh An commune Dong Nai, VN
1722028	Terumo BCT, Inc..	Lakewood, CO, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020981987. Last updated year: 2026. Please use registration number 3020981987 when referencing this establishment in official correspondence.