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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 Reagent Kit (Diluent and Lyse)

6970493090801016PA

2 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 Reagent Kit (Diluent and Lyse)
Basic UDI-DI
6970493090801016PA
Device model
PTD-1:25 tests/kit、PTD-1:50 tests/kit
Issuing agency
GS1
Version date
Jun 5, 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

ReagentNear-patient testingProfessional 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

2 references

Export results

Applied filters

  • basicUdiUlid·01KMZCPCW2R91961P8PVBJEJBH

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 Reagent Kit (Diluent and Lyse)12.02.0823A0697049309289650On the market
Hematology Analyzer Reagent Kit (Diluent and Lyse)12.02.0822A0697049309288925On the market