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Splint

by Anping Guardian Medical Equipment Co., Ltd 104 variants

Part of a family of 108 devices: see the family page

Ref AZ-TSETModel AZ-SPS

Splint (AZ-TSET) is a Class I device made by Anping Guardian Medical Equipment Co., Ltd, registered in EUDAMED on 9 Dec 2024 (Basic UDI-DI 697310523SPLINTPK), active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697310523SPLINTPK Basic UDI-DI 06973105232093UDI-DIDate9 Dec 2024RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
AZ-SPS, AZ-TSET
Primary DI / UDI-DI
06973105232093
Basic UDI-DI
697310523SPLINTPK
EMDN code
M03050299 Bandages and splints - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015025
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Related devices

Category: Hand/finger splint, reusable

Similar devices in this category

Other devices filed under BANDAGES AND SPLINTS - OTHER.

Other devices from Anping Guardian Medical Equipment Co., Ltd

See all devices from Anping Guardian Medical Equipment Co., Ltd →

Properties

Other properties (14, all answered No)