MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

Certificate 178/MDR

Rev. 4Supplemented

Valid until: Jul 2, 2029

Certificate 178/MDR is a valid Quality management system issued to MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. and registered in EUDAMED. Valid until July 2, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 178/MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051178/MDR4

Validity

Issued: Jun 18, 2026
Valid from: Jun 18, 2026
Valid until: Jul 2, 2029

Manufacturer

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

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

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

059/MDRSupplementedDec 19, 2025 → Jul 2, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa4Class IIb1

5 scopes

Pompe di infusione ambulatoriali / Ambulatory Infusion Pumps
Class IIb
Spirometri / Spirometers
Class IIa
Videoprocessore per endoscopia medica / Medical endoscope image processor
Class IIa
Endoscopio per il tratto gastrointestinale superiore / Upper gastrointestinal tract endoscope
Class IIa
Endoscopio per il tratto gastrointestinale inferiore / Lower gastrointestinal tract endoscope
Class IIa

Documents

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