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Optilite® Hevylite® IgM Kappa Kit
EUDAMEDFDA 510(k)Class C (EU MDR)
Ref NK625.OPT510(k) K152389
Identity
- Trade Name
- Optilite® Hevylite® IgM Kappa Kit EUDAMED
- Device Name
- Optilite® Hevylite® IgM Kappa Kit EUDAMED
- Model / Reference
- NK625.OPT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051700018104 EUDAMED
- Basic UDI-DI
- 5051700NK625.OPT97 EUDAMED
- EMDN Code
- W0102010107 IMMUNOGLOBULIN M EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
Optilite® Hevylite® IgM Kappa Kit by The Binding Site Group Ltd — Class C — FDA_510K, IVDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152389 | Class C | Active |
| EUDAMED | European Union | CE/IVDR | 5051700NK625.OPT97 | Class C | Active |
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Manufacturer
- Manufacturer
- The Binding Site Group Ltd
- EUDAMED SRN
- UK-MF-000036707
- FDA Applicant
- The Binding Site Group , Ltd.
- Authorised Representative
- The Binding Site Ireland Limited IE-AR-000034426
Sources (2)
- EUDAMED 05e02104-b52e-4363-9e2c-9bffb4e68fcc 85 fields · synced Jun 18, 2026
- FDA 510(k) K152389 1 fields · synced Jun 9, 2026