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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
  • WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

Data from EUDAMED, last updated Jun 12, 2026

COVID-19(SARS-CoV-2) Antigen Test Kit

B-06978896417568

1 reference

IVDD — Self-testing
Applicable legislation
IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Risk category
IVDD — Self-testing
Manufacturer
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.

Device family identification

Device name
COVID-19(SARS-CoV-2) Antigen Test Kit
Basic UDI-DI
B-06978896417568
Device model
Type:B-2 Tests/Kit Type S
Issuing agency
EUDAMED
Version date
May 29, 2026

Classification

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

Manufacturer & authorised representative

Manufacturer

Name
WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.
SRN
CN-MF-000019908
Country
China
Email
caoyue@ediagnosis.cn

Authorised representative

Name
OSMUNDA Medical Technology Service GmbH
SRN
DE-AR-000009285
Country
Germany
Phone
+49-30-81865123

Device characteristics

ReagentSelf-testing

EMDN code(s)

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

  • W0105099099Virology - rt & poc - other

References by status

Clinical investigations

Registered
No

Legacy certificates

Certificate number
1434-IVDD-079/2022
Type
refdata.legacy.ivdd-certificate-type.iii-6
Notified body
POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. (1434)
Validity
May 26, 2025

References

1 reference

Export results

Applied filters

  • basicUdiUlid·01KSSG8T3JA7Y0VVBP94YW0TMK

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
COVID-19(SARS-CoV-2) Antigen Test KitW-AgH-02S069788964175681On the market