Eu Mdr Eu Md Class 3 On The Market 🇨🇳 China

CAPTOR ®

Devices (same UDI-DI)
4
Certificates
1
Countries
1
Notified Bodies
1

Basic Information

Primary DI
06971145482041
Basic UDI-DI Code
697114548TDERF
Reference
HC*TDE-6020
Device Types
Single use Sterile
Regulation
Eu Mdr
Classification
Eu Md Class 3
Status
On The Market

Additional Description

The product is expected to be used to restore blood flow by removing thrombus from large intracranial vessels in patients with ischemic stroke within 8 hours of symptom onset. It is suitable for patients who cannot use intravenous tissue type plasminogen activator (IV t-PA) or IV t-PA treatment failure. The device is designed for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of middle cerebral artery, basilar, and vertebral arteries. This device includes radiopaque parts. (markers).

CND Nomenclature Codes

Code Description
C010401020501 MANUAL CARDIAC THROMBECTOMY AND THROMBOASPIRATION SYSTEMS

Certificates

Type Number
MDR Technical Documentation M.2023.MDR.1027-1

Available In Countries

🇭🇷 Croatia

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