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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
  • Wallac Oy

Data from EUDAMED, last updated May 23, 2026

Eonis SCID-SMA kit

6438147Eonis_SCID-SMA62

3 references

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

Device family identification

Device name
Eonis SCID-SMA kit
Basic UDI-DI
6438147Eonis_SCID-SMA62
Issuing agency
GS1
Version date
Jan 14, 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
Wallac Oy
SRN
FI-MF-000022620
Country
Finland
Email
regulatoryaffairs.turku@revvity.com
Phone
+3582 2678111

Device characteristics

ReagentProfessional testingHuman tissues / cellsAnimal tissues / cells

EMDN code(s)

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

  • W0106010299Polygenetic disorders tests - other

References by status

References

3 references

Export results

Applied filters

  • basicUdiUlid·01KEYAE3RNZFY1SKJ5J14P8309

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
Eonis SCID-SMA kit3241-0010064381473777251On the market
Eonis SCID-SMA kit3242-0010064381473777491On the market
Eonis SCID-SMA kit3241-0020064381473882401On the market