Identity
- Trade Name
- cobas IGRA SARS-CoV-2 Tubes EUDAMED
- Device Name
- cobas IGRA SARS-CoV-2 Tubes EUDAMED
- Model / Reference
- 9542507190 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800050290589 EUDAMED
- Basic UDI-DI
- B-08800050290589 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
cobas IGRA SARS-CoV-2 Tubes by Invitros Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08800050290589 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Invitros Co., Ltd
- EUDAMED SRN
- KR-MF-000023980
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED c08e29b3-17cc-446d-8e9d-264f11dc4f8a 61 fields · synced Jun 19, 2026