Identity
- Trade Name
- Optilite® IgG1 Kit EUDAMED
- Device Name
- Optilite® IgG1 Kit EUDAMED
- Model / Reference
- NK006.OPT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051700017060 EUDAMED
- Basic UDI-DI
- 5051700NK006.OPT5J EUDAMED
- EMDN Code
- W0102010106 IMMUNOGLOBULIN G SUBCLASS REAGENTS EUDAMED
Classification
- Device Class
- Class B 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® IgG1 Kit by The Binding Site Group Ltd — 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 | 5051700NK006.OPT5J | Class B | Active |
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Manufacturer
- Manufacturer
- The Binding Site Group Ltd
- EUDAMED SRN
- UK-MF-000036707
- Authorised Representative
- The Binding Site Ireland Limited IE-AR-000034426
Sources (1)
- EUDAMED b8865341-8fce-4486-a56c-584338997ee5 61 fields · synced May 21, 2026