MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

Certificate V13 086916 0064

Rev. Rev. 00Supplemented

Valid until: Dec 29, 2027

Certificate V13 086916 0064 is a valid Quality management system issued to MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. and registered in EUDAMED. Valid until December 29, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: V13 086916 0064
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0123V13 086916 0064Rev. 00

Validity

Issued: May 28, 2026
Valid from: May 28, 2026
Valid until: Dec 29, 2027

Manufacturer

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Linked SSCPs

Characteristics

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

History

Status changes

Supplemented
Supplemented

Supersedes

V12 086916 0037AmendedAug 26, 2025 → Dec 29, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

IVDR Class C3IVDR Class B1

4 scopes

IVR 0602 - Physiological markers: Specific disease
IVDR Class B
W0102 + IVP 3007 - Immunochemistry
IVDR Class C
W0103 + IVP 3005 - Haematology / Haemostasis / Immunohaematology / Histology / Cytology
IVDR Class C
W0103 + IVP 3007 - Haematology / Haemostasis / Immunohaematology / Histology / Cytology
IVDR Class C

Documents

LanguagesEN