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Ultrasonic Surgical Shears

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

Active European Union

Ref AH-638-B-TModel AH-638-B-L, AH-638-B-S, AH-638-B-T

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6970950282b009BA Basic UDI-DIDate2 Mar 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  • Withdrawn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

Model / Reference
AH-638-B-L, AH-638-B-S, AH-638-B-T
Primary DI / UDI-DI
06970950282532
Basic UDI-DI
6970950282b009BA
Direct Marketing DI
06970950282532
EMDN Code
K0202010102 Laparoscopic and thoracoscopic ultrasonic surgery scissors, single-use
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

Show 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