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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-10 · Link to EUDAMED

Sereny™ Hemostasis Introducer

UDI-DI 06931896166300Basic UDI-DI 69318961INS152SE

Class IIa · MDR · APT Medical Inc.

Identification
Model
4F, 5F, 6F, 7F, 8F
EMDN
C0502
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
No
Reusable surgical
No
Certificates

CN23/00002940

EU quality management system · unknown

Notified body: SGS Belgium NV (1639)

Valid from 2026-07-10 · Expiry 2028-06-06

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

APT Medical Inc.

SRN CN-MF-000009046

CN · Xiangxiang City, Hunan

manufacturer

Authorised representative: Shanghai International Holding Corp. GmbH(Europe) (DE-AR-000000001)

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Canonical device page: /device/serenytm-hemostasis-introducer-6300 · UDI page: /udi/06931896166300

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