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Disposable Endoscope Injection Needles

by Zhejiang Soudon Medical Technology Co., Ltd 23 variants

Ref SD-04-A2325-4Model SD-04-A、SD-04-B

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K232442↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697513704NE04HT Basic UDI-DI 06975137042466UDI-DIDate13 May 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK232442 Date9 Nov 2023IssuedStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Disposable Endoscope Injection Needles
Model / Reference
SD-04-A、SD-04-B, SD-04-A2325-4
Primary DI / UDI-DI
06975137042466
Basic UDI-DI
697513704NE04HT
Direct Marketing DI
06975137042466
EMDN Code
G03020101 Digestive endoscopy, single-lumen needles
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000021047
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

Other devices from Zhejiang Soudon Medical Technology Co., Ltd

See all devices from Zhejiang Soudon Medical Technology 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