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Tosoh Corporation

Japan·JP-MF-000024143

Last updated May 27, 2026

What Tosoh Corporation makes

Tosoh Corporation manufactures automated immunoassay systems and related reagent kits for in vitro diagnostic testing. Their product line includes test cups, calibrator sets, pretreatment cups, and sample diluting solutions for detecting markers such as Toxoplasma IgM, homocysteine, cytomegalovirus IgM, human chorionic gonadotropin (βHCGII), thyroid hormones (TT3), and follicle-stimulating hormone (FSH). These devices are designed for use in clinical laboratories to support diagnostic evaluations in areas like infectious disease, endocrinology, and fertility testing.

The company’s diagnostic products are classified under EU regulations as Class A, Class B, Class C, and IVD Annex II List B devices, with some falling under the broader IVD General category. These products are registered in the EU’s eudamed database, ensuring compliance with European Union regulatory requirements. Tosoh Corporation is headquartered in Japan.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Japan
Address: 2-2-1 Yaesu, Tokyo, Japan
Website: tosoh.co.jp
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 650-615-8134
PRRC Contact: Yutaka Tahara
EUDAMED SRN: JP-MF-000024143
FDA FEI Number: —
DUNS Number: 690571724

Catalogue (399)

Page 7 of 8

Device	Model / Reference	Registries	Class	Status
Cl Aia-Pack Pivka-Ii Adjuster Set	0029244	EUDAMED	IVD General	Active
ST AIA-PACK Homocysteine CALIBRATOR SET	0025326	EUDAMEDFDA UDI	IVD General	Active
G7 HSi Elution Buffer No.1 (S)	0019544	EUDAMED	IVD General	Active
Aia-Pack Sample Treatment Cup	0020971	EUDAMED	Class A	Active
Automated TRCR Real-time Monitor TRCReady-80	0023950	EUDAMED	Class A	Active
Aia-Pack Ck-Mb Sample Diluting Solution	0020569	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Prl Sample Diluting Solution	0020555	EUDAMEDFDA UDI	IVD General	Active
GR01 Elution Buffer No. 2	0024757	EUDAMED	Class C	Active
CL AIA-PACK TRAb TEST CUP	0029120	EUDAMED	IVD General	Active
CL AIA-PACK free PSA TEST CUP	0029117	EUDAMED	IVD Annex II List B	Active
Aia-Pack Substrate Set Ii	0020968	EUDAMEDFDA UDI	Class A	Active
ST AIA-PACK Testosterone SAMPLE DILUTING SOLUTION	0025504	EUDAMEDFDA UDI	IVD General	Active
AIA-PACK SLa CALIBRATOR SET	0020385	EUDAMED	IVD General	Active
CL AIA-PACK Prolactin ADJUSTER SET	0029229	EUDAMED	IVD General	Active
Cl Aia-Pack Sample Diluting Reagent B	0029402	EUDAMED	Class A	Active
St Aia-Pack Ovca	0025289	EUDAMED	IVD General	Active
CL AIA-PACK Ferritin ADJUSTER SET	0029236	EUDAMED	IVD General	Active
Cl Aia-Pack Sample Diluting Reagent C	0029403	EUDAMED	IVD General	Active
TSKgel GR01	0024755	EUDAMED	Class C	Active
CL AIA-PACK Toxo IgG TEST CUP	0029159	EUDAMED	IVD Annex II List B	Active
Cl Aia-Pack Ovca Adjuster Set	0029215	EUDAMED	IVD General	Active
ST AIA-PACK SLa	0025285	EUDAMED	IVD General	Active
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8	0021560	EUDAMEDFDA UDI	Class A	Active
CL AIA-PACK Progesterone ADJUSTER SET	0029222	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Osteocalcin TEST CUP	0029154	EUDAMED	IVD General	Active
ST AIA-PACK 25-OH Vitamin D PRETREATMENT SET	0025734	EUDAMEDFDA UDI	IVD General	Active
Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300	0024450	EUDAMEDFDA UDI	Class A	Active
TSKgel G8 β-Thal. HSi	0021929	EUDAMED	IVD General	Active
Aia-Pack Lhii Sample Diluting Solution	0020596	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Diluent Concentrate	0029704	EUDAMED	Class A	Active
Aia-Pack Tt3 Calibrator Set	0020382	EUDAMEDFDA UDI	IVD General	Active
St Aia-Pack Cortii Sample Diluting Solution	0025546	EUDAMED	IVD General	Active
Aia-Pack Bnp Control Set	0025428	EUDAMEDFDA UDI	IVD General	Active
AIA-PACK SLa SAMPLE DILUTING SOLUTION	0020585	EUDAMED	IVD General	Active
AIA-PACK IgE SAMPLE DILUTING SOLUTION	0020595	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Testosterone TEST CUP	0029130	EUDAMED	IVD General	Active
CL AIA-PACK ProlactinII ADJUSTER SET	0029271	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK TRAb ADJUSTER SET	0029220	EUDAMED	IVD General	Active
G7 Variant Elution Buffer HSi No.2 (S)	0019553	EUDAMED	IVD General	Active
Cl Aia-Pack Hcg Test Cup	0029123	EUDAMED	IVD General	Active
290 Sample Loader G11-290SL	0023853	EUDAMED	Class A	Active
Cl Aia-Pack Sample Diluting Reagent E	0029405	EUDAMED	Class A	Active
CL AIA-PACK TPOAb TEST CUP	0029118	EUDAMED	IVD General	Active
ST AIA-PACK Myoglobin	0025297	EUDAMEDFDA UDI	IVD General	Active
Automated Enzyme Immunoassay System Aia-360	0019945	EUDAMEDFDA UDI	Class A	Active
AIA-PACK TPOAb	0020290	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET	0025334	EUDAMEDFDA UDI	IVD General	Active
G8 Elution Buffer HSi No.3 (S)	0021802	EUDAMED	IVD General	Active
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01LA	0024751	EUDAMED	Class A	Active
G11 F&A2 Calibrator Set	0023508	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Tosoh Europe N.V. BE

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Tosoh Corp. US