MD Atlas update: Aug 5, 2026

KAMIYA BIOMEDICAL COMPANY, LLC

US-MF-000002769

Active77 devices

Address: 12779 Gateway Drive S., 98168 Tukwila, WA
Role: Manufacturer
Date of registration: Apr 9, 2021
Country: United States

KAMIYA BIOMEDICAL COMPANY, LLC is a medical device manufacturer registered in EUDAMED. The company has 77 devices on the EU market across 17 countries. Headquartered in Tukwila, WA, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About KAMIYA BIOMEDICAL COMPANY, LLC

: US-MF-000002769
Role: Manufacturer
Country: United States
Organization name: KAMIYA BIOMEDICAL COMPANY, LLC
EU VAT number: Not applicable
Date of registration: Apr 9, 2021

Contact details for KAMIYA BIOMEDICAL COMPANY, LLC

Phone: +1 206-575-8068
Email: info@k-assay.com
Website: https://www.k-assay.com/
Address: 12779 GATEWAY DRIVE S. 98168 TUKWILA, WA UNITED STATES

Competent authority

Name: Malta Medicines Authority

Phone: +356 23439000
Email: devices.medicinesauthority@gov.mt

Officers and regulatory representatives of KAMIYA BIOMEDICAL COMPANY, LLC

YOSHIMURA Satsuki
Ensuring that the conformity of the devices is appropriately checked in accordance with the QMS before a device is released, drawing up technical documentation and the EU declaration of conformity and keeping them up-to-date, complying with post-market surveillance obligations, reporting serious incidents and field safety corrective actions to relevant competent authorities, and all other requirements in Article 15 of the EU IVDR.
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GETTY Colin
Ensuring that the conformity of the devices is appropriately checked in accordance with the QMS before a device is released, drawing up technical documentation and the EU declaration of conformity and keeping them up-to-date, complying with post-market surveillance obligations, reporting serious incidents and field safety corrective actions to relevant competent authorities, and all other requirements in Article 15 of the EU IVDR.
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Connected operators

Importers

2 EU importers place this manufacturer's devices

Data export

Export the 77 devices of KAMIYA BIOMEDICAL COMPANY, LLC

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Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Coagulation Control	Coagulation Control	`K204C-10M`	`00816426021013`	1	On the market
Coagulation Control	Coagulation Control	`K204C-10M`	`00816426021013`	1	On the market
Factor XIII	Factor XIII	`KAI-205`	`00816426020535`	1	On the market
Factor XIII	Factor XIII	`KAI-205`	`00816426020535`	1	On the market
Factor XIII Calibrator	Factor XIII Calibrator	`KAI-206C`	`00816426020764`	1	On the market
Factor XIII Calibrator	Factor XIII Calibrator	`KAI-206C`	`00816426020764`	1	On the market
K-ASSAY Alpha-1 Microglobulin	K-ASSAY Alpha-1 Microglobulin	`KAI-056`	`00816426020283`	1	On the market
K-ASSAY Apo AI	K-ASSAY Apo AI	`KAI-002`	`00816426020016`	1	On the market
K-ASSAY Apo AI/B Control	K-ASSAY Apo AI/B Control	`K310C-4M`	`00816426021648`	1	On the market
K-ASSAY Apo AII	K-ASSAY Apo AII	`KAI-003`	`00816426020023`	1	On the market
K-ASSAY Apo AII / CII / CIII / E Control	K-ASSAY Apo AII / CII / CIII / E Control	`K315C-4M`	`00816426021662`	1	On the market
K-ASSAY Apo AII/CII/CIII Calibrator	K-ASSAY Apo AII/CII/CIII Calibrator	`KAI-041C`	`00816426020580`	1	On the market
K-ASSAY Apo B	K-ASSAY Apo B	`KAI-004`	`00816426020030`	1	On the market
K-ASSAY Apo CII	K-ASSAY Apo CII	`KAI-005`	`00816426020047`	1	On the market
K-ASSAY Apo CIII	K-ASSAY Apo CIII	`KAI-006`	`00816426020054`	1	On the market
K-ASSAY Apo E	K-ASSAY Apo E	`KAI-007`	`00816426020061`	1	On the market
K-ASSAY Apo E Calibrator	K-ASSAY Apo E Calibrator	`KAI-025C`	`00816426020436`	1	On the market
K-ASSAY ASO	K-ASSAY ASO	`KAI-078`	`00816426020337`	1	On the market
K-ASSAY ASO Calibrator	K-ASSAY ASO Calibrator	`KAI-079C`	`00816426020627`	1	On the market
K-ASSAY ASO/RF/CRP Control	K-ASSAY ASO/RF/CRP Control	`K55C-4M`	`00816426020856`	1	On the market
K-ASSAY Beta-2 Microglobulin	K-ASSAY Beta-2 Microglobulin	`KAI-280`	`00816426021280`	1	On the market
K-ASSAY Beta-2 Microglobulin Serum/Plasma Calibrator	K-ASSAY Beta-2 Microglobulin Serum/Plasma Calibrator	`KAI-281C`	`00816426021297`	1	On the market
K-ASSAY Beta-2 Microglobulin Urine Calibrator	K-ASSAY Beta-2 Microglobulin Urine Calibrator	`KAI-282C`	`00816426021303`	1	On the market
K-ASSAY Beta-2 Microglobulin/Ferritin - Serum/Plasma Control	K-ASSAY Beta-2 Microglobulin/Ferritin - Serum/Plasma Control	`K283C-4M`	`00816426021327`	1	On the market
K-ASSAY Complement C3	K-ASSAY Complement C3	`KAI-009`	`00816426020078`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Coagulation Control	Coagulation Control	`K204C-10M`	`00816426021013`	1	On the market
Coagulation Control	Coagulation Control	`K204C-10M`	`00816426021013`	1	On the market
Factor XIII	Factor XIII	`KAI-205`	`00816426020535`	1	On the market
Factor XIII	Factor XIII	`KAI-205`	`00816426020535`	1	On the market
Factor XIII Calibrator	Factor XIII Calibrator	`KAI-206C`	`00816426020764`	1	On the market
Factor XIII Calibrator	Factor XIII Calibrator	`KAI-206C`	`00816426020764`	1	On the market
K-ASSAY Alpha-1 Microglobulin	K-ASSAY Alpha-1 Microglobulin	`KAI-056`	`00816426020283`	1	On the market
K-ASSAY Apo AI	K-ASSAY Apo AI	`KAI-002`	`00816426020016`	1	On the market
K-ASSAY Apo AI/B Control	K-ASSAY Apo AI/B Control	`K310C-4M`	`00816426021648`	1	On the market
K-ASSAY Apo AII	K-ASSAY Apo AII	`KAI-003`	`00816426020023`	1	On the market
K-ASSAY Apo AII / CII / CIII / E Control	K-ASSAY Apo AII / CII / CIII / E Control	`K315C-4M`	`00816426021662`	1	On the market
K-ASSAY Apo AII/CII/CIII Calibrator	K-ASSAY Apo AII/CII/CIII Calibrator	`KAI-041C`	`00816426020580`	1	On the market
K-ASSAY Apo B	K-ASSAY Apo B	`KAI-004`	`00816426020030`	1	On the market
K-ASSAY Apo CII	K-ASSAY Apo CII	`KAI-005`	`00816426020047`	1	On the market
K-ASSAY Apo CIII	K-ASSAY Apo CIII	`KAI-006`	`00816426020054`	1	On the market
K-ASSAY Apo E	K-ASSAY Apo E	`KAI-007`	`00816426020061`	1	On the market
K-ASSAY Apo E Calibrator	K-ASSAY Apo E Calibrator	`KAI-025C`	`00816426020436`	1	On the market
K-ASSAY ASO	K-ASSAY ASO	`KAI-078`	`00816426020337`	1	On the market
K-ASSAY ASO Calibrator	K-ASSAY ASO Calibrator	`KAI-079C`	`00816426020627`	1	On the market
K-ASSAY ASO/RF/CRP Control	K-ASSAY ASO/RF/CRP Control	`K55C-4M`	`00816426020856`	1	On the market
K-ASSAY Beta-2 Microglobulin	K-ASSAY Beta-2 Microglobulin	`KAI-280`	`00816426021280`	1	On the market
K-ASSAY Beta-2 Microglobulin Serum/Plasma Calibrator	K-ASSAY Beta-2 Microglobulin Serum/Plasma Calibrator	`KAI-281C`	`00816426021297`	1	On the market
K-ASSAY Beta-2 Microglobulin Urine Calibrator	K-ASSAY Beta-2 Microglobulin Urine Calibrator	`KAI-282C`	`00816426021303`	1	On the market
K-ASSAY Beta-2 Microglobulin/Ferritin - Serum/Plasma Control	K-ASSAY Beta-2 Microglobulin/Ferritin - Serum/Plasma Control	`K283C-4M`	`00816426021327`	1	On the market
K-ASSAY Complement C3	K-ASSAY Complement C3	`KAI-009`	`00816426020078`	1	On the market

KAMIYA BIOMEDICAL COMPANY, LLC

About KAMIYA BIOMEDICAL COMPANY, LLC

Contact details for KAMIYA BIOMEDICAL COMPANY, LLC

Competent authority

Officers and regulatory representatives of KAMIYA BIOMEDICAL COMPANY, LLC

Connected operators

Importers

Export the 77 devices of KAMIYA BIOMEDICAL COMPANY, LLC

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About KAMIYA BIOMEDICAL COMPANY, LLC

Contact details for KAMIYA BIOMEDICAL COMPANY, LLC

Competent authority

Officers and regulatory representatives of KAMIYA BIOMEDICAL COMPANY, LLC

Statistics for KAMIYA BIOMEDICAL COMPANY, LLC

Certificate health for KAMIYA BIOMEDICAL COMPANY, LLC

Related documents

Devices by risk class

Device catalog for KAMIYA BIOMEDICAL COMPANY, LLC

Device families (Basic UDI-DI) of KAMIYA BIOMEDICAL COMPANY, LLC

Market presence of KAMIYA BIOMEDICAL COMPANY, LLC

Connected operators

Importers

Export the 77 devices of KAMIYA BIOMEDICAL COMPANY, LLC

Related searches

Certificate health for KAMIYA BIOMEDICAL COMPANY, LLC

Statistics for KAMIYA BIOMEDICAL COMPANY, LLC

Market presence of KAMIYA BIOMEDICAL COMPANY, LLC

Devices by risk class

Related documents

Device families (Basic UDI-DI) of KAMIYA BIOMEDICAL COMPANY, LLC

Device catalog for KAMIYA BIOMEDICAL COMPANY, LLC