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Sinnowa

by SINNOWA Medical Science & Technology Co., Ltd

Model DS-161, DS-261, DS- 301, DS-401,DS- 405,DS-612，DS- 812,BS-3000M，BS- 3000P,BS-3000,CH- 12，CH-24

Active European Union

CE IVDR

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697138538BA001AZ Basic UDI-DI 06971385381128UDI-DIDate10 Jan 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Biochemistry Analyzer
Model / Reference
DS-161, DS-261, DS- 301, DS-401, DS- 405, DS-612，DS- 812, BS-3000M，BS- 3000P, BS-3000, CH- 12，CH-24
Primary DI / UDI-DI
06971385381128
Basic UDI-DI
697138538BA001AZ
EMDN Code
W0201010101, W0201010102, W0201010103, W0201010104, W0201010105, W0201010106, W0201010107, W0201010108, W0201010180, W0201010182, W0201010185, W0201010192
Device Class
Class A
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000032436
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No