Identity
- Trade Name
- Sight OLO EUDAMED
- Device Name
- Sight OLO EUDAMED
- Model / Reference
- OLO-E1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B787OLOE10 EUDAMED
- Basic UDI-DI
- B-B787OLOE10 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Sight OLO by S.D. Sight Diagnostics 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-B787OLOE10 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- S.D. Sight Diagnostics Ltd
- EUDAMED SRN
- IL-MF-000026216
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 927bab81-d570-4834-a8c1-bc5f33583ae2 61 fields · synced Jul 8, 2026