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Bestar

by Wuhan Bestar Industry Co., Ltd 529 variants

Ref BSH2040, BSA3003, BSB1026, BSB1143, BSF4035, BSAC5001, BSH2056, BSH2009, BSB1078, BSB1159, BSB1221, BSH2020, BSF4001, BSH2016Model BSH20CP, BSA30SC, BSB10LB, BSB11AP, BSF40SC, BSAC50B, BSB1074, BSB12SG, BSF40BC

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697531648BSH20CPQR Basic UDI-DI Date7 Feb 2023RegisteredStatusActive

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  • Withdrawn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
Cap
Oversleeve
Lab Coat
Apron
Shoe Cover
Bed Sheet
Face Mask
Isolation Gown
Surgical Gown
Boot Cover
Model / Reference
BSH20CP, BSH2040, BSA30SC, BSA3003, BSB10LB, BSB1026, BSB11AP, BSB1143, BSF40SC, BSF4035, BSAC50B, BSAC5001, BSH2056, BSH2009, BSB1074, BSB1078, BSB1159, BSB12SG, BSB1221, BSH2020, BSF40BC, BSF4001, BSH2016
Primary DI / UDI-DI
16975316488358, 16975316487245, 16975316483018, 16975316484107, 16975316487016, 16975316489010, 16975316488181, 16975316480017, 16975316482042, 16975316483520, 16975316485012, 16975316488075, 16975316487306, 16975316488013, 06975316483714, 16975316483704, 16975316483711, 16975316488488, 06975316487309, 16975316488457, 16975316484336, 06975316487019, 06975316484339, 06975316488078, 16975316484282, 16975316488518, 06975316484285, 06975316484322, 06975316488351, 16975316488495, 06975316484292, 06975316483011, 06975316483523, 16975316484343, 06975316488467, 06975316488184, 16975316484305, 16975316488464, 06975316484308, 06975316480010, 06975316483707, 06975316488504, 06975316482045, 06975316488481, 06975316484346, 06975316485015, 16975316488471, 06975316488511, 06975316489013, 06975316487248
Basic UDI-DI
697531648BSH20CPQR, 697531648BSA30SCP9, 697531648BSB10LBNF, 697531648BSB11APNF, 697531648BSF40SCR7, 697531648BSAC50BQ3, 697531648BSH2009MP, 697531648BSB10IGNG, 697531648BSB12SGPQ, 697531648BSF40BCPL
EMDN Code
T0299, T0208, T020699, T020499, T0207, T020603, T020401, T030502
Device Class
Class I
EU market of registration
Italy
Spain

Manufacturer details

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

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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