Identity
- Trade Name
- Optitrol Mumps M, 2x pos, 1mL EUDAMED
- Device Name
- Optitrol Mumps M, 1x pos, 1mL EUDAMED
- Model / Reference
- SR15065 EUDAMEDSR15068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850075957057 EUDAMED
- Basic UDI-DI
- 0816784020091Y6 EUDAMED
- EMDN Code
- W0105080804 OTHER VIROLOGY 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 Mumps M, 2x 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 | 0816784020091Y6 | 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 f4046a3d-725e-4d49-ac9f-9c3bb6c88541 61 fields · synced Aug 1, 2026