MD Atlas
BlogPricingSign in
MD Atlas
Made In Tracker
Made In TrackerEasyUDI
Legal
Privacy PolicyLegal Notice
About
AboutFAQBlogPartnersContact

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

Subscribe to our monthly newsletter:

  • MD Atlas
  • Shandong Bohong Gene Technology Co., Ltd.

Data from EUDAMED, last updated Jun 12, 2026

5-Part Auto Hematology Analyzer

69749019722AHA5***HE

5 references

IVDR Class A
Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class A
Manufacturer
Shandong Bohong Gene Technology Co., Ltd.

Device family identification

Device name
5-Part Auto Hematology Analyzer
Basic UDI-DI
69749019722AHA5***HE
Device model
BH-HA610, BH-HA510, BH-HA630, BH-HA640, BH-HA650, etc.
Issuing agency
GS1
Version date
May 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
Shandong Bohong Gene Technology Co., Ltd.
SRN
CN-MF-000025971
Country
China
Email
base@biobase.cn

Authorised representative

Name
Luxus Lebenswelt GmbH
SRN
DE-AR-000005110
Country
Germany
Phone
+49 1715605732

Device characteristics

Professional testing

EMDN code(s)

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

  • W0202010101Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)
  • W0202010102Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr)

References by status

References

5 references

Export results

Applied filters

  • basicUdiUlid·01KSF59Y9QSBM8100PCFPNKN1C

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
5-Part Auto Hematology AnalyzerW02020101069749019722991On the market
5-Part Auto Hematology AnalyzerBH-HA510069749019722821On the market
5-Part Auto Hematology AnalyzerBH-HA650069749019723121On the market
5-Part Auto Hematology AnalyzerBH-HA640069749019723051On the market
5-Part Auto Hematology AnalyzerBH-HA610069749019722751On the market