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CureSight
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NSP-000200Model CS100510(k) K221375
Identity
- Trade Name
- CureSight EUDAMED
- Device Name
- CureSight EUDAMED
- Model / Reference
- CS100 EUDAMEDNSP-000200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290019059400 EUDAMED
- Basic UDI-DI
- 7290019059CS100TQ EUDAMED
- EMDN Code
- Z12120204 SYNOPTISCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CureSight by NovaSight Ltd. — Class IIa — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221375 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 7290019059CS100TQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- NovaSight Ltd.
- EUDAMED SRN
- IL-MF-000011872
- FDA Applicant
- Novasight , Ltd.
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 7c27643a-25bd-4f2c-8240-8a0b62511762 85 fields · synced Jun 18, 2026
- FDA 510(k) K221375 1 fields · synced May 18, 2026