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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 1 of 8

Device	Model / Reference	Registries	Class	Status
CL AIA-PACK Toxo IgM ADJUSTER SET	0029262	EUDAMED	Class C	Active
CL AIA-PACK Homocysteine TEST CUP	0029186	EUDAMED	Class B	Active
CL AIA-PACK CMV IgM ADJUSTER SET	0029261	EUDAMED	Class C	Active
CL AIA-PACK Homocysteine PRETREATMENT CUP	0029586	EUDAMED	Class B	Active
CL AIA-PACK Toxo IgM TEST CUP	0029162	EUDAMED	Class C	Active
CL AIA-PACK Homocysteine ADJUSTER SET	0029286	EUDAMED	Class B	Active
St Aia-Pack Βhcgii Calibrator Set	0025320	EUDAMED	IVD General	Active
501rp+	0023295	EUDAMED	Class A	Active
CL AIA-PACK hGH ADJUSTER SET	0029235	EUDAMED	IVD General	Active
St Aia-Pack Tt3	0025282	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Fsh Sample Diluting Solution	0020565	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Fsh Adjuster Set	0029227	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Ft4 Adjuster Set	0029203	EUDAMED	IVD General	Active
AIA-PACK IgEII CALIBRATOR SET	0020395	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK Osteocalcin	0025236	EUDAMED	IVD General	Active
TSKgel G11 β-Thal.	0023504	EUDAMED	IVD General	Active
CL AIA-PACK CMV IgG ADJUSTER SET	0029257	EUDAMED	IVD Annex II List B	Active
ST AIA-PACK C-PeptideII SAMPLE DILUTING SOLUTION	0025583	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Prolactin TEST CUP	0029129	EUDAMED	IVD General	Active
290 Sample Loader G8-290SL	0021562	EUDAMEDFDA UDI	Class A	Active
Cl Aia-Pack Shbg Test Cup	0029139	EUDAMED	IVD General	Active
Aia-Pack Cea Sample Diluting Solution	0020554	EUDAMEDFDA UDI	IVD General	Active
AIA-PACK Homocysteine CONTROL SET	0025426	EUDAMEDFDA UDI	IVD General	Active
Automated Enzyme Immunoassay Analyzer Aia-2000 La	0022101	EUDAMEDFDA UDI	Class A	Active
290 Sample Loader GR-290SL	0024753	EUDAMED	Class A	Active
Cl Aia-Pack Shbg Adjuster Set	0029239	EUDAMED	IVD General	Active
Aia-Pack B12 Pretreatment Set	0020706	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Hcg Adjuster Set	0029223	EUDAMED	IVD General	Active
St Aia-Pack Scc Calibrator Set	0025337	EUDAMED	IVD General	Active
CL AIA-PACK Thyroglobulin ADJUSTER SET	0029206	EUDAMED	IVD General	Active
Cl Aia-Pack Afp Test Cup	0029107	EUDAMED	IVD General	Active
TRCR Purification Kit	0056201	EUDAMED	Class A	Active
Cl Aia-Pack Dhea-S Test Cup	0029165	EUDAMED	IVD General	Active
F&A2 Calibrator Set 2	0023550	EUDAMED	IVD General	Active
St Aia-Pack Pivka-Ii	0025233	EUDAMED	IVD General	Active
St Aia-Pack Pivka-Ii Calibrator Set	0025333	EUDAMED	IVD General	Active
G11 Variant Elution Buffer No. 3 (S)	0023481	EUDAMED	IVD General	Active
G8 β-Thalassemia Diluting Solution (S)	0021931	EUDAMED	IVD General	Active
ST AIA-PACK Homocysteine PRETREATMENT SET	0025726	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Rbc Folate Sample Diluting Solution	0020514	EUDAMEDFDA UDI	IVD General	Active
St Aia-Pack Dhea-S Sample Diluting Solution	0025522	EUDAMEDFDA UDI	IVD General	Active
St Aia-Pack Shbg Calibrator Set	0025338	EUDAMEDFDA UDI	IVD General	Active
G8 Hemoglobin F&A2 Calibrator	0021932	EUDAMED	IVD General	Active
Aia-Pack Ovca Sample Diluting Solution	0020589	EUDAMED	IVD General	Active
Cl Aia-Pack Βhcg Adjuster Set	0029228	EUDAMED	IVD General	Active
ST AIA-PACK D-Dimer	0025232	EUDAMED	IVD General	Active
Cl Aia-Pack Wash Concentrate	0029703	EUDAMED	Class A	Active
St Aia-Pack Progiii Sample Diluting Solution	0025540	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION	0025513	EUDAMEDFDA UDI	IVD General	Active
AIA-PACK TPOAb CONJUGATE	0020708	EUDAMEDFDA UDI	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