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iSR'obot Mona Lisa 2.0
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref iSR'obot Bed Rail Stabilizer
Identity
- Device Name
- iSR'obot Mona Lisa 2.0 EUDAMED
- Model / Reference
- iSR'obot Bed Rail Stabilizer EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885014610399 EUDAMED
- Basic UDI-DI
- 888501461iSRobot25 EUDAMED
- EMDN Code
- Z12169099 VARIOUS INSTRUMENTS FOR UROLOGY - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
iSR'obot Mona Lisa 2.0 by Biobot Surgical Pte. 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
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 | K232320 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K213411 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 888501461iSRobot25 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biobot Surgical Pte Ltd
- EUDAMED SRN
- SG-MF-000020631
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e1be157a-0878-4c6e-b011-c642dd4e5fb5 61 fields · synced Oct 6, 2026
- FDA 510(k) K232320 1 fields · synced May 18, 2026