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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
  • Phadia AB

Data from EUDAMED, last updated May 31, 2026

ImmunoCAP Specific IgG4

7333066BUDI0067ME

1 reference

IVDR Class B
Applicable legislation
IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Risk category
IVDR Class B
Manufacturer
Phadia AB

Device family identification

Device name
ImmunoCAP Specific IgG4
Basic UDI-DI
7333066BUDI0067ME
Issuing agency
GS1
Version date
Mar 25, 2026

Classification

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

Manufacturer

Manufacturer

Name
Phadia AB
SRN
SE-MF-000014170
Country
Sweden
Email
RegulatoryAffairs.Uppsala.IDD@thermofisher.com
Phone
+46 18 165000

Device characteristics

ReagentProfessional testingAnimal tissues / cells

EMDN code(s)

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

  • W0102010106Immunoglobulin g subclass reagents

References by status

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KMJSDYB5NMHD22N46KPB4E20

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
ImmunoCAP Specific IgG4 Conjugate 5010-9549-01073330660227891On the market