Identity
- Device Name
- Respiratory Antigens Negative Control EUDAMED
- Model / Reference
- 1-867-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902643958869 EUDAMED
- Basic UDI-DI
- 59026439BRTK867QX EUDAMED
- EMDN Code
- W0105080899 CONTROLS - INF. IMMUNOLOGY - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Respiratory Antigens Negative Control by BioMaxima Spółka Akcyjna — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 59026439BRTK867QX | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioMaxima Spółka Akcyjna
- EUDAMED SRN
- PL-MF-000039473
Sources (1)
- EUDAMED 9dfecd6a-062e-4e20-935c-2940a6d42c1b 61 fields · synced Oct 6, 2026