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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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  • MD Atlas
  • C-Luminary Biotechnology Co., Ltd.

Data from EUDAMED, last updated Jun 11, 2026

Sharay hs-cTnI (CLIA)

B-06975070762476

1 reference

IVDD — General
Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — General
Manufacturer
C-Luminary Biotechnology Co., Ltd.

Device family identification

Device name
Sharay hs-cTnI (CLIA)
Basic UDI-DI
B-06975070762476
Issuing agency
EUDAMED
Version date
May 23, 2024

Classification

Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — General
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
C-Luminary Biotechnology Co., Ltd.
SRN
CN-MF-000035089
Country
China
Email
xianjing@c-luminary.com

Authorised representative

Name
Sungo Cert GmbH
SRN
DE-AR-000010869
Country
Germany

Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

EMDN code(s)

European Medical Device Nomenclature — the EU product classifications carried across this device family's references.

  • W01021306Troponin i/t

References by status

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01HYJ231R04HMZHY6G45D7YNG9

Format

Summary

31 columns included
  • Trade name
  • Basic UDI-DI
  • UDI-DI code
  • Risk category
  • Applicable legislation
  • Status
  • Organization name
  • SRN
  • Reference / catalog number
  • Additional product description
  • Intended medical purpose
  • Market country
  • Issuing entity
  • Market info update date
  • Sterile
  • Single use
  • Contains latex
  • Reprocessed single-use
  • Direct marking
  • CMR substance
  • Endocrine disruptor
  • Annex XVI applicable
  • Sterilization
  • OEM applicable
  • EMDN codes
  • Last updated
  • Basic UDI-DI device name
  • Basic UDI-DI device model
  • Basic UDI-DI implantable
  • Basic UDI-DI reagent
  • DM Atlas link
Trade nameReference / catalog numberUDI-DI codeQuantityStatus
Sharay hs-cTnI (CLIA)18305101069750707624761On the market