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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 4 of 8

Device	Model / Reference	Registries	Class	Status
G7 Variant Elution Buffer HSi No.1 (S)	0019552	EUDAMED	IVD General	Active
Auto-Prep Unit for AIA-CL1200	0024132	EUDAMEDFDA UDI	Class A	Active
G8 Variant Elution Buffer HSi No.2 (S)	0021850	EUDAMED	IVD General	Active
St Aia-Pack Fsh	0025265	EUDAMEDFDA UDI	IVD General	Active
HbA1c Calibrator Set (S)	0023502	EUDAMED	IVD General	Active
Cl Aia-Pack T3 Adjuster Set	0029204	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Rubella IgG TEST CUP	0029156	EUDAMED	IVD Annex II List B	Active
CL AIA-PACK Cortisol SAMPLE DILUTING REAGENT	0029438	EUDAMED	IVD General	Active
Cl Aia-Pack T3 Test Cup	0029104	EUDAMEDFDA UDI	IVD General	Active
Automated Enzyme Immunoassay Analyzer Aia-900	0022930	EUDAMEDFDA UDI	Class A	Active
ST AIA-PACK iFT3	0025231	EUDAMED	IVD General	Active
Hemoglobin A1c Control Set	0021974	EUDAMED	Class C	Active
ST AIA-PACK Presepsin CALIBRATOR SET	0025342	EUDAMED	IVD General	Active
Aia-Pack T4 Sample Diluting Solution	0020558	EUDAMEDFDA UDI	IVD General	Active
Extragen Zr	0056203	EUDAMED	Class A	Active
Tosoh Automated Glycohemoglobin Analyzer HLC-723G11 LA	0023851	EUDAMED	Class A	Active
ST AIA-PACK Testosterone	0025204	EUDAMEDFDA UDI	IVD General	Active
AIA-PACK TgAb CONJUGATE	0020709	EUDAMEDFDA UDI	IVD General	Active
AIA-PACK TPOAb CALIBRATOR SET	0020390	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK TRAb SAMPLE DILUTING REAGENT	0029420	EUDAMED	IVD General	Active
ST AIA-PACK Cystatin C SAMPLE DILUTING SOLUTION	0025517	EUDAMEDFDA UDI	IVD General	Active
G8 Variant Elution Buffer HSi No.1 (S)	0021849	EUDAMED	IVD General	Active
ST AIA-PACK Presepsin	0025242	EUDAMED	IVD General	Active
CL AIA-PACK Anti-SARS-CoV-2-SP-IgG ADJUSTER SET	0029272	EUDAMED	IVD General	Active
St Aia-Pack Tsh	0025294	EUDAMEDFDA UDI	IVD General	Active
TSKgel G7 Variant HSi	0019680	EUDAMEDFDA UDI	IVD General	Active
Cl Aia-Pack Ft4 Test Cup	0029103	EUDAMED	IVD General	Active
St Aia-Pack Afp	0025252	EUDAMEDFDA UDI	IVD General	Active
ST AIA-PACK Intact PTH CALIBRATOR SET	0025313	EUDAMEDFDA UDI	IVD General	Active
Aia-Pack Shbg Control Set	0025438	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Folate ADJUSTER SET	0029255	EUDAMED	IVD General	Active
TRCReady SARS-CoV-2 NE	0056110	EUDAMED	IVD General	Active
Aia-Pack Afp Calibrator Set	0020352	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK 25-OH Vitamin D TEST CUP	0029146	EUDAMED	IVD General	Active
ST AIA-PACK Cystatin C CALIBRATOR SET	0025317	EUDAMEDFDA UDI	IVD General	Active
CL AIA-PACK Anti-SARS-CoV-2-NP TEST CUP	0029179	EUDAMED	IVD General	Active
G8 Elution Buffer HSi No.1 (S)	0021800	EUDAMED	IVD General	Active
CL AIA-PACK SLa TEST CUP	0029113	EUDAMED	IVD General	Active
AIA-PACK Osteocalcin CONTROL SET	0025436	EUDAMED	IVD General	Active
CL AIA-PACK ProlactinII TEST CUP	0029171	EUDAMEDFDA UDI	IVD General	Active
GR01 Elution Buffer No. 1	0024756	EUDAMED	Class C	Active
Cl Aia-Pack Ft3 Test Cup	0029102	EUDAMED	IVD General	Active
G11 β-Thalassemia Elution Buffer No. 3(S)	0023507	EUDAMED	IVD General	Active
Cl Aia-Pack Diluent Concentrate	0029708	EUDAMED	Class A	Active
St Aia-Pack Bnp	0025228	EUDAMED	IVD General	Active
CL AIA-PACK TgAb ADJUSTER SET	0029219	EUDAMED	IVD General	Active
St Aia-Pack Kl-6 Calibrator Set	0025344	EUDAMED	IVD General	Active
AIA-900 9tray Sorter	0022931	EUDAMEDFDA UDI	Class A	Active
AIA-PACK Thyroglobulin CONTROL SET	0025427	EUDAMED	IVD General	Active
St Aia-Pack Iri	0025260	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