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Splint

by Shenzhen Aonuo Medical Technology Co., Ltd. EUDAMED

Active European Union

Model AN-401,AN-402,AN-403,AN-404,AN-405,AN-406,AN-407,AN-408,AN-409（or customized）

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697539269ANSPTR Basic UDI-DIDate27 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Splint
Model / Reference
AN-401, AN-402, AN-403, AN-404, AN-405, AN-406, AN-407, AN-408, AN-409（or customized）
Primary DI / UDI-DI
06975392694080
Basic UDI-DI
697539269ANSPTR
EMDN Code
M03050299 Bandages and splints - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038823
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Hand/finger splint, reusable

Other devices from Shenzhen Aonuo Medical Technology Co., Ltd.

See all devices from Shenzhen Aonuo Medical Technology Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • 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