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Tinto Estrogen Receptor, RM292, RMab
EUDAMEDClass IVD General (EU MDR)
Ref BSB-3765-3Ref BSB-3765-7Ref BSB-3765-15
by Bio SB Inc
Identity
- Trade Name
- Tinto Estrogen Receptor, RM292, RMab EUDAMED
- Device Name
- Tinto Estrogen Receptor, RM292, RMab EUDAMED
- Model / Reference
- BSB-3765-3 EUDAMEDBSB-3765-7 EUDAMEDBSB-3765-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B502BSB376530 EUDAMEDB502BSB376570 EUDAMEDB502BSB3765150 EUDAMED
- Basic UDI-DI
- B-B502BSB376530 EUDAMEDB-B502BSB376570 EUDAMEDB-B502BSB3765150 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
Tinto Estrogen Receptor, RM292, 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-B502BSB376530 | 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 (3)
- EUDAMED 2c195377-29e9-482f-a9a1-92c67e695c2b 61 fields · synced Jul 19, 2026
- EUDAMED 58ce1204-cd77-4e19-80ac-c1fb35acf69c 61 fields · synced May 18, 2026
- EUDAMED f639fbe0-f9df-4c21-8f88-79db81076029 61 fields · synced May 18, 2026