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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
  • Eurospital Spa

Data from EUDAMED, last updated May 30, 2026

Eu-Gen MTHFR Dual-Type (100 Test)/(25 Test)

802816920CW01060402055E

2 references

IVDR Class C
Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class C
Manufacturer
Eurospital Spa

Device family identification

Device name
Eu-Gen MTHFR Dual-Type (100 Test)/(25 Test)
Basic UDI-DI
802816920CW01060402055E
Device model
Eu-Gen MTHFR Dual-Type
Issuing agency
GS1
Version date
Feb 27, 2026

Classification

Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class C
Status
On the market

Manufacturer

Manufacturer

Name
Eurospital Spa
SRN
IT-MF-000028468
Country
Italy
Email
regulatory@eurospital.it
Phone
+3904089971

Device characteristics

ReagentProfessional testing

EMDN code(s)

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

  • W0106010499Polymorphism tests - other

References by status

Clinical investigations

Registered
No

References

2 references

Export results

Applied filters

  • basicUdiUlid·01KJFHWYC4RK0RY6YSGP4MZK12

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
94639463080281692089091On the market
9463S9463S080281692089161On the market