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Bestar

by Wuhan Bestar Industry Co., Ltd

Ref BSH2155

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number16975316480031 UDI-DI Date19 Dec 2022ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697531648BSH2155N3 Basic UDI-DI Date28 Apr 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Public face mask, single-use
Device Name
Disposable Medical Non-Woven Face Mask (Type IIR)
Model / Reference
BSH2155
Primary DI / UDI-DI
16975316480031, 06975316480034
Basic UDI-DI
697531648BSH2155N3
FDA Product Code
KHA
EMDN Code
T020604 Medical use face masks, type II and iir
GMDN Term
Public face mask, single-use
Device Class
Class I
Regulation Number
868.5590
EU market of registration
Germany
Spain
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CN-MF-000023005
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wuhan Bestar Industry Co., Ltd

See all devices from Wuhan Bestar Industry Co., Ltd →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No