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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 2 of 8

Device	Model / Reference	Registries	Class	Status
ST AIA-PACK free PSA SAMPLE DILUTING SOLUTION	0025511	EUDAMED	IVD Annex II List B	Active
AIA-PACK TPOAb CONTROL SET	0020490	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK 25-OH Vitamin D	0025234	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK β2-Microglobulin ADJUSTER SET	0029241	EUDAMED	IVD General	Active
90 Sample Loader G11-90SL	0023852	EUDAMED	Class A	Active
Cl Aia-Pack Dhea-S Adjuster Set	0029265	EUDAMED	IVD General	Active
CL AIA-PACK Presepsin ADJUSTER SET	0029266	EUDAMED	IVD General	Active
Cl Aia-Pack Bnp Test Cup	0029109	EUDAMED	IVD General	Active
St Aia-Pack Βhcgii Sample Diluting Solution	0025520	EUDAMED	IVD General	Active
ST AIA-PACK hsE2	0025225	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack B12 Calibrator Set	0020393	EUDAMEDFDA UDI	IVD General	Active
St Aia-Pack Shbg	0025238	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Lh Adjuster Set	0029224	EUDAMEDFDA UDI	IVD General	Active
TSKgel G7 β-Thal. HSi	0019681	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Acth Adjuster Set	0029245	EUDAMED	IVD General	Active
Cl Aia-Pack Scc Test Cup	0029147	EUDAMED	IVD General	Active
Aia-Pack Bmg Calibrator Set	0020359	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Tsh Adjuster Set	0029201	EUDAMED	IVD General	Active
St Aia-Pack Pap	0025262	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Cortisol ADJUSTER SET	0029238	EUDAMED	IVD General	Active
Aia-Pack Acth Control Set	0025421	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Anti-SARS-CoV-2-SP-IgG TEST CUP	0029178	EUDAMED	IVD General	Active
St Aia-Pack Βhcgii	0025220	EUDAMED	IVD General	Active
St Aia-Pack Cortii Calibrator Set	0025346	EUDAMED	IVD General	Active
CL AIA-PACK Cortisol TEST CUP	0029138	EUDAMED	IVD General	Active
St Aia-Pack Lhii	0025296	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Hgh Sample Diluting Solution	0020566	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Ovca Test Cup	0029115	EUDAMED	IVD General	Active
CL AIA-PACK Toxo IgG ADJUSTER SET	0029259	EUDAMED	IVD Annex II List B	Active
GX Elution Buffer No. 2 (S)	0023511	EUDAMED	IVD General	Active
CL AIA-PACK cTnI ADJUSTER SET	0029226	EUDAMED	IVD General	Active
CL AIA-PACK TPOAb ADJUSTER SET	0029218	EUDAMED	IVD General	Active
CL AIA-PACK cTnI TEST CUP	0029126	EUDAMED	IVD General	Active
AIA-900 19tray Sorter	0022932	EUDAMEDFDA UDI	Class A	Active
CL AIA-PACK Estradiol ADJUSTER SET	0029221	EUDAMED	IVD General	Active
CL AIA-PACK Vitamin B12 TEST CUP	0029167	EUDAMED	IVD General	Active
Automated Enzyme Immunoassay Analyzer Aia-2000 St	0022100	EUDAMEDFDA UDI	Class A	Active
AIA-PACK Presepsin CONTROL SET	0025442	EUDAMED	IVD General	Active
Cl Aia-Pack Afp Adjuster Set	0029207	EUDAMED	IVD General	Active
ST AIA-PACK Osteocalcin SAMPLE DILUTING SOLUTION	0025536	EUDAMED	IVD General	Active
St Aia-Pack Dhea-S Calibrator Set	0025322	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Ferritin TEST CUP	0029136	EUDAMED	IVD General	Active
TSKgel GX	0023160	EUDAMED	IVD General	Active
CL AIA-PACK D-Dimer ADJUSTER SET	0029242	EUDAMED	IVD General	Active
Aia-Pack Folate Calibrator Set	0020392	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Intact PTH ADJUSTER SET	0029240	EUDAMED	IVD General	Active
G8 β-Thalassemia Elution Buffer Kit	0021930	EUDAMED	IVD General	Active
CL AIA-PACK hGH TEST CUP	0029135	EUDAMED	IVD General	Active
St Aia-Pack Bnp Calibrator Set	0025328	EUDAMEDFDA UDI	IVD General	Active
Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01	0024750	EUDAMED	Class A	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