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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
  • Jiangxi Hongda Medical Equipment Group Ltd.

Data from EUDAMED, last updated Jun 11, 2026

Hollow fiber hemodialyzer low-flux

69207567KXXWTXQ00028Y

1 reference

Class IIb
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIb
Manufacturer
Jiangxi Hongda Medical Equipment Group Ltd.

Device family identification

Device name
Hollow fiber hemodialyzer low-flux
Basic UDI-DI
69207567KXXWTXQ00028Y
Device model
HD-10L,HD-12L,HD-13L,HD-14L,HD-15L,HD-16L,HD-17L,HD-18L,HD-19L,HD-20L
Issuing agency
GS1
Version date
Mar 30, 2026

Classification

Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Risk category
Class IIb
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Jiangxi Hongda Medical Equipment Group Ltd.
SRN
CN-MF-000006019
Country
China
Email
zkb@jxhd.cn
Phone
+86-791-85628828

Authorised representative

Name
Shanghai International Holding Corp. GmbH(Europe)
SRN
DE-AR-000000001
Country
Germany
Phone
+49 40 2513175

Device characteristics

No device characteristics flagged

EMDN code(s)

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

  • F01060103Dialysers - ufc < 18 ml/h/mmhg, synthetic membranes

References by status

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KMYS2KF6YXQAKSC6DT657D9J

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
Hollow fiber hemodialyzer low-fluxHD-14L-001669207567185391On the market