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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
  • Shenzhen Dymind Biotechnology Co., Ltd.

Data from EUDAMED, last updated Jun 11, 2026

Hematology Analyzer Lyse

697049309W010300000119T

9 references

IVDR Class A
Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class A
Manufacturer
Shenzhen Dymind Biotechnology Co., Ltd.

Device family identification

Device name
Hematology Analyzer Lyse
Basic UDI-DI
697049309W010300000119T
Device model
LYC-1:1L
Issuing agency
GS1
Version date
Mar 25, 2026

Classification

Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class A
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Shenzhen Dymind Biotechnology Co., Ltd.
SRN
CN-MF-000024842
Country
China
Email
regulationdept@dymind.com

Authorised representative

Name
Eunitor GmbH
SRN
DE-AR-000005081
Country
Germany

Device characteristics

ReagentProfessional testing

EMDN code(s)

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

  • W0103010105Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)

References by status

References

9 references

Export results

Applied filters

  • basicUdiUlid·01KMHY3429083905C0Z3XT0SY5

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
Hematology Analyzer Lyse12.01.1357A069704930928101On the market
Hematology Analyzer Lyse12.01.1414A069704930913631On the market
Hematology Analyzer Lyse12.01.1415A069704930913701On the market
Hematology Analyzer Lyse12.01.1411A069704930913181On the market
Hematology Analyzer Lyse12.01.1417A069704930914171On the market
Hematology Analyzer Lyse12.01.1356A069704930913871On the market
Hematology Analyzer Lyse12.01.1355A069704930913251On the market
Hematology Analyzer Lyse12.01.1354A069413773012981On the market
Hematology Analyzer Lyse12.01.1412A069704930913491On the market