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Huayuan

by Huayuan Medical Technology(Shangqiu) Co., Ltd. 6 variants

Ref nitrile,cobalt blue,M, nitrile,blue,XL, nitrile,cobalt blue,L, nitrile,cobalt blue,S, nitrile,blue,LModel nitrile,blue,S

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697434321NBR-HYSQ-01WH Basic UDI-DI Date25 Mar 2022RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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

Device Name
Medical Examination Gloves
Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs
Model / Reference
nitrile, blue, S, cobalt blue, M, XL, L
Primary DI / UDI-DI
06974343210058, 06974343210034, 06974343210065, 06974343210041, 06974343210027, 06974343210102
Basic UDI-DI
697434321NBR-HYSQ-01WH, 697434321NBR-HYSQ-02WK
EMDN Code
T01020204 Nitrile examination / treatment gloves
Device Class
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000018982
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Huayuan Medical Technology(Shangqiu) 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