APT Medical Inc.

Certificate CN23/00002940

Rev. 3Supplemented

Valid until: Jun 6, 2028

Certificate CN23/00002940 is a valid Quality management system issued to APT Medical Inc. and registered in EUDAMED. Valid until June 6, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: CN23/00002940
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 1639CN23/000029403

Validity

Issued: Mar 20, 2024
Valid from: Mar 20, 2024
Valid until: Jun 6, 2028

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

CN23/00002940Quality management systemSupplementedNov 22, 2023 → Jun 6, 2028

Scope coverage

Class IIa3Class III2Class I2

7 scopes

MDN1203, MDS1005
Class III
MDN1208
Class I
MDN1202 MDS1005
Class IIa
DEVICE
Class III
DEVICE
Class I
Sterile SealingPro™ Y Connector Type I, Type II, Type II-01, Type III, Type IV, Type short I
Class IIa
Sterile SealingPro™ Y Connector Type short I, Type II, Type II-01, Type III and Type IV:
Class IIa

Documents

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