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Shigella boydii polyvalent 1 (1-6) Agglutinating Serum
EUDAMEDClass IVD General (EU MDR)
Ref R30163901
Identity
- Trade Name
- Shigella boydii polyvalent 1 (1-6) Agglutinating Serum EUDAMED
- Device Name
- SHIGELLA AGGLUTINATING SERUM EUDAMED
- Model / Reference
- R30163901 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056080500928 EUDAMED
- Basic UDI-DI
- B-05056080500928 EUDAMED
- EMDN Code
- W0104080301 SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Shigella boydii polyvalent 1 (1-6) Agglutinating Serum by Remel Europe Ltd — 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-05056080500928 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Remel Europe Ltd
- EUDAMED SRN
- GB-MF-000016733
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (1)
- EUDAMED 5fcae915-cd52-4b0b-8585-0562094ad011 61 fields · synced Sep 30, 2026