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HSD Medical face mask Type IIR

by Wuhan Huashida Protective Products Co., Ltd

Ref HSD-TYP2RModel Type IIR Surgical face mask (non-sterile)

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221352↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69732170801V7 Basic UDI-DI 06973217080179UDI-DIDate31 Mar 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK221352 Date13 Mar 2023IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device Name
Surgical face mask (non-sterile)
Model / Reference
Type IIR Surgical face mask (non-sterile), HSD-TYP2R
Primary DI / UDI-DI
06973217080179
Basic UDI-DI
69732170801V7
Direct Marketing DI
06973217080179
EMDN Code
T020604 Medical use face masks, type II and iir
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000001293
Authorised representative
Lotus NL B.V. NL-AR-000000121

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