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Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab
EUDAMEDClass IVD General (EU MDR)
Ref BSB 3473Ref BSB 3474Ref BSB 3472
by Bio SB Inc
Identity
- Trade Name
- Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab EUDAMED
- Device Name
- Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab EUDAMED
- Model / Reference
- BSB 3473 EUDAMEDBSB 3474 EUDAMEDBSB 3472 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B502BSB34730 EUDAMEDB502BSB34740 EUDAMEDB502BSB34720 EUDAMED
- Basic UDI-DI
- B-B502BSB34730 EUDAMEDB-B502BSB34740 EUDAMEDB-B502BSB34720 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
Herpes Simplex Virus I and II, 10A3 and BSB-116, MMab 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-B502BSB34730 | 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 c1c78788-9675-48ca-893c-541b4f14cd70 61 fields · synced Jul 28, 2026
- EUDAMED f1d2e942-a357-4d2a-ae3f-7f8e3e33c661 61 fields · synced May 18, 2026
- EUDAMED 183e6cb5-0f67-4c67-ab00-261d2cb61a0e 61 fields · synced May 19, 2026