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iSR'obot Mona Lisa
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref iSR'obot Mona Lisa Ref iSR'obot Floor Stand Stabilizer
Identity
- Device Name
- iSR'obot Mona Lisa EUDAMEDiSR'obot Mona Lisa 2.0 EUDAMED
- Model / Reference
- iSR'obot Mona Lisa EUDAMEDiSR'obot Floor Stand Stabilizer EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885014610351 EUDAMED08885014610429 EUDAMED
- Basic UDI-DI
- B-08885014610351 EUDAMED888501461iSRobot25 EUDAMED
- EMDN Code
- Z12169099 VARIOUS INSTRUMENTS FOR UROLOGY - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands 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 by Biobot Surgical Pte. Ltd. — Class IIa — FDA_510K, MDR, MDD — 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111347 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K130944 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-08885014610351 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08885014610351 | 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 (3)
- EUDAMED d59795d0-0233-40d2-9161-dde30e88fd83 61 fields · synced Jul 18, 2026
- EUDAMED 71aacb05-a3d3-4142-8efc-9bad92a9c618 61 fields · synced May 18, 2026
- FDA 510(k) K111347 1 fields · synced May 18, 2026