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Bacterial Antigen polyvalent control +
EUDAMEDClass IVD General (EU MDR)
Ref 5901Ref 5902
Identity
- Trade Name
- Bacterial Antigen polyvalent control + EUDAMEDBacterial Antigen polyvalent control - EUDAMED
- Device Name
- Bacterial Antigen polyvalent control + EUDAMEDBacterial Antigen polyvalent control - EUDAMED
- Model / Reference
- 5901 EUDAMED5902 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05404035102107 EUDAMED05404035102114 EUDAMED
- Basic UDI-DI
- B-05404035102107 EUDAMEDB-05404035102114 EUDAMED
- EMDN Code
- W0105080801 BACTERIOLOGY CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Bacterial Antigen polyvalent control + by Cypress Diagnostics — 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-05404035102107 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Cypress Diagnostics
- EUDAMED SRN
- BE-MF-000000033
Sources (2)
- EUDAMED faa318ba-bf21-4b2a-bd21-4093029e84da 61 fields · synced Jul 9, 2026
- EUDAMED 4c6d89f3-553d-4af0-8709-5f10a57ef474 61 fields · synced May 16, 2026