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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

697049309W01030000009A8

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
697049309W01030000009A8
Device model
LYA-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·01KMHYQEAQS794EK9A434TAVWM

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 Lyse12.01.1422A069704930967571On the market
Hematology Analyzer Lyse12.01.1421A069704930967191On the market
Hematology Analyzer Lyse12.01.1358A069704930966891On the market
Hematology Analyzer Lyse12.01.1419A069704930967021On the market
Hematology Analyzer Lyse12.01.1423A069704930967881On the market
Hematology Analyzer Lyse12.01.1359A069704930966721On the market
Hematology Analyzer Lyse12.01.1360A069704930967331On the market
Hematology Analyzer Lyse12.01.1363A069704930967641On the market
Hematology Analyzer Lyse12.01.1361A069704930967261On the market