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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
  • Assure Tech. (Hangzhou) Co., Ltd.

Data from EUDAMED, last updated Jun 12, 2026

Automatic Chemiluminesence Immunoanalyzer

69528048GB01F00AX

1 reference

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

Device family identification

Device name
Automatic Chemiluminesence Immunoanalyzer
Basic UDI-DI
69528048GB01F00AX
Device model
CLI1000
Issuing agency
GS1
Version date
Jun 2, 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
Assure Tech. (Hangzhou) Co., Ltd.
SRN
CN-MF-000002170
Country
China
Email
contact@diareagent.com
Phone
+(86)571-81022698

Authorised representative

Name
Lotus NL B.V.
SRN
NL-AR-000000121
Country
Netherlands
Phone
+31644168999

Device characteristics

Professional testing

EMDN code(s)

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

  • W0201069099Various rapid test chemistry / immunochemistry instruments - other

References by status

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KT3KANHDP6AXV52ZPZB52AYA

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
Automatic Chemiluminesence ImmunoanalyzerCLI1000069528048124781On the market