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Electrosurgical Vessel Sealer/Divider

by Affacare Medical (Beijing) Co., Ltd. EUDAMED

Active European Union

Ref AH-163XP-44LModel AH-16319-23, AH-16319-37, AH-16319-44, AH-163XP-23S, AH-163XP-37S, AH-163XP-44S, AH-163XP-23L, AH-163XP-37L, AH-163XP-44L, AH-1637-21

Overview

The Electrosurgical Vessel Sealer/Divider is a medical device designed for vessel sealing and division, providing a safe and effective solution for various surgical procedures. With its advanced technology and precision engineering, this device ensures precise control and minimal trauma to the patient.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6970950282b014B3 Basic UDI-DIDate30 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
AH-16319-23, AH-16319-37, AH-16319-44, AH-163XP-23S, AH-163XP-37S, AH-163XP-44S, AH-163XP-23L, AH-163XP-37L, AH-163XP-44L, AH-1637-21
Primary DI / UDI-DI
06970950282303
Basic UDI-DI
6970950282b014B3
EMDN Code
K0201010201, K0201010202
Device Class
Class IIb
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000025388
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Affacare Medical (Beijing) Co., Ltd.

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No