APT Medical Inc.

Certificate CN26/00004348

Rev. 1Issued

Valid until: Jun 15, 2031

Certificate CN26/00004348 is a valid Quality management system issued to APT Medical Inc. and registered in EUDAMED. Valid until June 15, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: CN26/00004348
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639CN26/000043481

Validity

Issued: Jun 15, 2026
Valid from: Jun 15, 2026
Valid until: Jun 15, 2031

Manufacturer

Manufacturer: APT Medical Inc.
Manufacturer SRN: CN-MF-000010698
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

No specific devices are listed for this certificate.

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III6

6 scopes

MDN1203, MDS1005
Class III
Sterile Triguy Steerable Ablation Catheter Standard type/ Intended purpose: It is intended for cardiac electrophysiological mapping ( stimulation and recording) and for cardiac ablation when used in conjunction with an RF generator
Class III
Sterile Triguy Steerable Ablation Catheter Irrigated type/ Intended purpose: It is intended for cardiac electrophysiological mapping ( stimulation and recording) and for cardiac ablation when used in conjunction with an RF generator
Class III
Sterile Triguy Mapping Catheter Fixed Curve / Intended purpose: It is intended for cardiac electrophysiological mapping (stimulation and recording) during diagnostic electrophysiology studies
Class III
Sterile Triguy Mapping Catheter Steerable Curve / Intended purpose: It is intended for cardiac electrophysiological mapping (stimulation and recording) during diagnostic electrophysiology studies
Class III
Sterile FastMap HD Mapping Catheter Curve shape D and F/ Intended purpose: It is intended for multiple electrodes electrophysiological mapping, including recording or stimulation, to obtain intracardiac electrograms. The catheter provides location information when used with Navigation System.
Class III

Documents

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