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Electrosurgical Vessel Sealer/Divider

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

Active European Union

Ref AH-163XP-37LModel 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

Regulatory status

as of 27 Oct 2026

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

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Electrosurgical Vessel Sealer/Divider
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
06970950282297
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.

See all devices from Affacare Medical (Beijing) Co., Ltd. →

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