Identity
- Trade Name
- Optitrol NAT Parvo B19, 5x 1.2 mL EUDAMED
- Device Name
- Optitrol NAT Parvo B19, 5x 1.2 mL EUDAMED
- Model / Reference
- NT05021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850075956760 EUDAMED
- Basic UDI-DI
- 0816784020103XL EUDAMED
- EMDN Code
- W0105080808 ALL INFECTIOUS DISEASES CONTROLS - NAT 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 NAT Parvo B19, 5x 1.2 mL 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 | 0816784020103XL | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LGC Clinical Diagnostics, Inc.
- EUDAMED SRN
- US-MF-000016356
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (1)
- EUDAMED 1d3874c7-03d5-4e74-a9b4-78ab1f1d1d36 61 fields · synced Jun 19, 2026