Terumo BCT Vietnam Co., Ltd.

FDA Device Registration & Listing · Binh An commune Dong Nai, VN · Registration 3011720361

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
3011720361
FEI Number
3011720361
Entity Name
Terumo BCT Vietnam Co., Ltd.
City/State/Country
Binh An commune Dong Nai, VN
Establishment Address
Long Duc Industrial Park, Binh An commune Dong Nai 76208, VN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Terumo BCT, INC. (Owner Number: 9002708)
Owner / Operator Contact Address
10811 WEST COLLINS AVE., --, Lakewood, CO 80215, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Trima Accel Platelet, Plasma Set Trima Accel Platelet + Sampler, Plasma, RBC Set Trima Accel System Trima LRS Platelet, Plasma, RBC Autopas Set IMUGARD WB PLT Platelet Pooling Set Trima Accel Platelet + Sampler, Plasma, RBC Set (ISBT) Trima Accel System - Quiet Pumps Trima Accel Auto RBC, Plasma Set Trima Accel LRS Platelet, Plasma, RBC Set Trima Accel RBC, Plasma Set Trima Accel Platelet + Sampler, Plasma, Auto RBC Set Trima Accel LRS Platelet, Plasma Set Trima Accel LRS Platelet + Sampler, Plasma, RBC Set Trima Accel Platelet + Sampler, MultiPlasma RBC Set Traim Accel MultiPlasma Set Trima Accel LRS Platelet, Plasma, RBC + Auto PAS Set Trima Accel LRS Platelet + Auto PAS, Plasma, Auto RBC Set Trima Accel Platelet, Plasma, Auto RBC Set Trima Accel LRS Platelet + 35 mL Sampler Multiplasma RBC Set Platelet Additive Solution Connection Adapter Trima Accel LRS Platelet, Plasma, Auto RBC Set Anticoagulant Connection Adapter Trima Accel LRS Platelet + 35 mL Sampler, Plasma, Auto RBC Set Trima Accel Platelet Plasma RBC Set Trima Platelet Sampler Plasma RBC Set Trima Platelet + Sampler Plasma RBC Set Trima Accel LRS Platelet, Plasma, RBC Set (ISBT) Trima Accel RBC Platelet/Plasma Trima Accel LRS Platelet, Plasma Set (ISBT)

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 2016-09-28
GKT Separator, Automated, Blood Cell, Diagnostic Hematology Class 2 864.9245 2013-10-28
KSR Container, Empty, For Collection & Processing Of Blood & Blood Components Hematology Class 2 864.9100 2022-09-06
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 2016-08-18
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 2016-08-18

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
1722028 Terumo BCT, Inc.. Lakewood, CO, US
1724474 Terumo BCT STERILIZATION SERVICES, 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 3011720361. Last updated year: 2026. Please use registration number 3011720361 when referencing this establishment in official correspondence.
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