Skip to content

Sinmed

by Promisemed Hangzhou Meditech Co., Ltd. China EUDAMED

Ref SHU-2015CHYModel Type A;Type B;Type D;Type E;

EMDN A01010301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697122740SHUR9 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Safety Huber Needles
Model / Reference
Type A, Type B, Type D, Type E, SHU-2015CHY
Primary DI / UDI-DI
06978111922426, 06975965297502
Basic UDI-DI
697122740SHUR9
Unit of Use DI
86978111922422, 86975965297508
EMDN Code
A01010301 Needles and kits for implantable systems (port), with safety systems
Device Class
Class IIa
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000008465
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Promisemed Hangzhou Meditech Co., Ltd.

See all devices from Promisemed Hangzhou Meditech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (2)

  • EUDAMED 00e08225-6369-4032-b85a-8b2ae949ecea 61 fields · synced 22 Oct 2026
  • EUDAMED 06975965297502|697122740SHUR9 61 fields · synced 18 Sep 2026