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Candida Albicans, RBT-C.alb, RMab
EUDAMEDClass IVD General (EU MDR)
Ref BSB-3803-01Ref BSB-3803-1
by Bio SB Inc
Identity
- Trade Name
- Candida Albicans, RBT-C.alb, RMab EUDAMED
- Device Name
- Candida Albicans, RBT-C.alb, RMab EUDAMED
- Model / Reference
- BSB-3803-01 EUDAMEDBSB-3803-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B502BSB3803010 EUDAMEDB502BSB380310 EUDAMED
- Basic UDI-DI
- B-B502BSB3803010 EUDAMEDB-B502BSB380310 EUDAMED
- EMDN Code
- W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
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
New Device
No
EUDAMED
Candida Albicans, RBT-C.alb, RMab by Bio Sb, Inc. — 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-B502BSB3803010 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Bio SB Inc
- EUDAMED SRN
- US-MF-000036462
- Authorised Representative
- QAdvis EAR AB SE-AR-000001599
Sources (2)
- EUDAMED 128c3052-b2a3-45b2-8d1e-65d918bec27f 61 fields · synced Jul 22, 2026
- EUDAMED ea7f806d-dcbf-4cd1-937e-3870a392726a 61 fields · synced May 18, 2026