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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
  • Xiamen Innodx Biotech Co., Ltd.

Data from EUDAMED, last updated Jun 11, 2026

INNODX FT4 CMIA

B-KR-FT4-03100KF

1 reference

IVDD — General
Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — General
Manufacturer
Xiamen Innodx Biotech Co., Ltd.

Device family identification

Device name
INNODX FT4 CMIA
Basic UDI-DI
B-KR-FT4-03100KF
Issuing agency
EUDAMED
Version date
May 21, 2026

Classification

Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — General
Status
On the market

Manufacturer & authorised representative

Manufacturer

Name
Xiamen Innodx Biotech Co., Ltd.
SRN
CN-MF-000041071
Country
China
Email
kr.ra@innodx.com
Phone
+86 0592-6807333

Authorised representative

Name
Medunion S.L.
SRN
ES-AR-000019366
Country
Spain
Phone
+34644173535

Device characteristics

ReagentProfessional testingAnimal tissues / cells

EMDN code(s)

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

  • W01020402Free thyroxine

References by status

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KS42ZADMDZY5G8XB50SW7876

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
INNODX FT4 CMIAKR-FT4-03100D-KR-FT4-03100KF1On the market