KAWASUMI LABORATORIES (THAILAND) CO., LTD.

FDA Device Registration & Listing · CHOK CHAI Nakhon Ratchasima, TH · Registration 9615908

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
9615908
FEI Number
3003282181
Entity Name
KAWASUMI LABORATORIES (THAILAND) CO., LTD.
City/State/Country
CHOK CHAI Nakhon Ratchasima, TH
Establishment Address
48 MU 8, RATCHASIMA-CHOK CHAI RD,, TAMBON THA ANG, AMPHOE, CHOK CHAI Nakhon Ratchasima 30190, TH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SB-KAWASUMI LABORATORIES, INC. (Owner Number: 8031539)
Owner / Operator Contact Address
3-25-4 Tonomachi, Kawasaki-ku, Kawasaki-shi, JP-14 210-8602, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K921901
PMA Number
N/A

All Registered Proprietary Names

Haemonetics Cell Saver System Haemonetics Cell Saver Elite System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-03-03
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-03-14
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-06-09
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2023-06-09
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2011-01-07
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-03-03
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2019-07-09
FIE Needle, Fistula Gastroenterology, Urology Class 2 876.5540 2010-04-21
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2010-04-21
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2018-10-11
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2018-10-11
KSB Set, Transfer (Blood/Plasma) Hematology Class 2 864.9875 2018-10-11
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2019-05-06
FIE Needle, Fistula Gastroenterology, Urology Class 2 876.5540 2010-04-21
CAC Apparatus, Autotransfusion Anesthesiology Class 2 868.5830 2015-09-17
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2008-03-03
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2008-03-03
FRN Pump, Infusion General Hospital Class 2 880.5725 2008-01-09

Official Correspondent

Kenichi Inamura

US Agent Details

Deno Zachary Business: MIC International Email: dzachary@micinternational.com Phone: (917) 3315789

Related Public Records

Same Entity

SB-KAWASUMI LABORATORIES, 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
3010141954 Sumitomo Bakelite (Dongguan) Co., Ltd. Dongguan Guangdong, CN
3002806337 Akita Sumitomo Bakelite Co., Ltd. Akita, JP
1055927 KAWASUMI LABORATORIES AMERICA, INC. Tampa, FL, 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615908. Last updated year: 2026. Please use registration number 9615908 when referencing this establishment in official correspondence.
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