Tosoh Corporation

Certificate HX 2048822-1

Rev. 3Supplemented

Valid until: Sep 12, 2029

Certificate HX 2048822-1 is a valid Quality management system issued to Tosoh Corporation and registered in EUDAMED. Valid until September 12, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 2048822-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 4
Certificate ID: 0197HX 2048822-13

Validity

Issued: Jun 16, 2026
Valid from: Jun 16, 2026
Valid until: Sep 12, 2029

Manufacturer

Manufacturer: Tosoh Corporation
Manufacturer SRN: JP-MF-000024143
Manufacturer country: Japan

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Supplemented

Supersedes

HX 2048822-1Quality management systemSupplementedFeb 10, 2026 → Sep 12, 2029

Scope coverage

IVDR Class C6IVDR Class B2

8 scopes

IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0608: Devices intended to be used for screening, determination or monitoring of physiological markers W01021307 HOMOCYSTEINE
IVDR Class B
HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYTOLOGY IVR 0601: Devices intended to be used for screening/confirmation of specific disorders/impairments W01030102 HAEMOGLOBIN (TYPES) TESTING
IVDR Class B
CLINICAL CHEMISTRY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)
IVDR Class C
W01010502 SPECIFIC CONTROLS (CLINICAL CHEMISTRY)
IVDR Class C
W01010503 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY)
IVDR Class C
INFECTIOUS DESEASES IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050401 - RUBELLA VIRUS
IVDR Class C
W01050402 - CYTOMEGALOVIRUS
IVDR Class C
W01050501 - TOXOPLASMA
IVDR Class C

Documents

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