Identity
- Trade Name
- Optitrol HIV 2, 1x pos, 1mL EUDAMED
- Device Name
- Optitrol HIV 2, 4x pos, 2.5mL EUDAMED
- Model / Reference
- SR11113 EUDAMEDSR11115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850075956913 EUDAMED
- Basic UDI-DI
- 0816784020110XH EUDAMED
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Optitrol HIV 2, 1x pos, 1mL by LGC Clinical Diagnostics, Inc. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0816784020110XH | Class B | Active |
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Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 68ea85d7-b590-41a3-951c-5ad8510ba853 61 fields · synced Jul 10, 2026