MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

Certificate G15 086916 0062

Rev. Rev. 01Supplemented

Valid until: Aug 7, 2028

Certificate G15 086916 0062 is a valid Quality management system issued to MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. and registered in EUDAMED. Valid until August 7, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: G15 086916 0062
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G15 086916 0062Rev. 01

Validity

Issued: Jun 22, 2026
Valid from: Jun 22, 2026
Valid until: Aug 7, 2028

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.

Characteristics

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

History

Status changes

Supplemented

Supersedes

G15 086916 0062SupplementedJun 27, 2025 → Aug 7, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb7Class IIa2

9 scopes

MDA 0306 - Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis
Class IIa
Z12030301 - INFUSION PUMPS
Class IIb
Z12030301 - INFUSION PUMPS
Class IIb
Z12030302 - SYRINGE PUMPS
Class IIb
Z12030302 - SYRINGE PUMPS
Class IIb
Z12030306 - INFUSION AND SYRINGE PUMP CONTROL SYSTEMS
Class IIb
Z12030306 - INFUSION AND SYRINGE PUMP CONTROL SYSTEMS
Class IIb
MDA 0313 - Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport
Class IIa
Z12030101 - ANAESTHESIA SYSTEMS
Class IIb

Documents

LanguagesEN