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Total Protein Kit (Biuret Method)

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Ref 105-015588-00Model 105-015586-00、105-015587-00、105-015588-00, TPⅡ0104

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69449040004BTP*********UJ Basic UDI-DI 06936415926397UDI-DIDate5 Sep 2022RegisteredStatusActive
European UnionCE/IVDR Number69449040004BTP*********UJ Basic UDI-DI 06936415926397UDI-DIDate5 Sep 2022RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Model / Reference
105-015586-00、105-015587-00、105-015588-00, 105-015588-00, TPⅡ0104
Primary DI / UDI-DI
06936415926397
Basic UDI-DI
69449040004BTP*********UJ, B-06936415926397
EMDN Code
W01010230 Total protein
Device Class
Class B
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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