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Hospiwell

by Hangzhou Topco Technology Group Co., Ltd. China EUDAMED

Ref H06001Model H06001, H06002, H06003, H06004, H06005, H06006

EMDN T020604

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697762345TOPCOMFMVK Basic UDI-DIDate5 Jul 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Medical face mask (Disposable Medical Face Mask)
Model / Reference
H06001, H06002, H06003, H06004, H06005, H06006
Primary DI / UDI-DI
06977623456016
Basic UDI-DI
697762345TOPCOMFMVK
EMDN Code
T020604 Medical use face masks, type ii and iir
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000042884
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Topco Technology Group Co., Ltd.

See all devices from Hangzhou Topco Technology Group Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 2254600e-d65f-41de-8130-451851cb05b0 61 fields · synced 24 Oct 2026