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Medical Polymeric Splint

by Hebei Sanxin Pharmaceutical Technology Co., Ltd. EUDAMED

Active European Union

Ref Front430x500x3.2/Rear410x460x3.2Model 120x195x2.4 145x230x2.4 155x250x2.4 170x270x2.4 220x250x2.4 190x290x2.4 155x310x2.4 175x320x2.4 190x340x2.4 195x360x2.4 238x480x2.4 175x500x2.4 218x590x2.4 295x610x3.2 etc.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697890768MPS3L Basic UDI-DIDate31 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
120x195x2.4 145x230x2.4 155x250x2.4 170x270x2.4 220x250x2.4 190x290x2.4 155x310x2.4 175x320x2.4 190x340x2.4 195x360x2.4 238x480x2.4 175x500x2.4 218x590x2.4 295x610x3.2 etc., Front430x500x3.2/Rear410x460x3.2
Primary DI / UDI-DI
06978907680202
Basic UDI-DI
697890768MPS3L
EMDN Code
M03050202 Synthetic cast bandages and splints
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057708
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hebei Sanxin Pharmaceutical Technology Co., Ltd.

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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