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iSR'obot Mona Lisa 2.0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref iSR'obot Mona Lisa 2.0
Identity
- Trade Name
- iSR'obot Mona Lisa FDA UDI
- Generic Name
- Prostate stereotactic biopsy/ablation system FDA UDI
- Device Name
- iSR'obot Mona Lisa 2.0 EUDAMED
- Model / Reference
- iSR'obot Mona Lisa 2.0 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08885014610382 EUDAMEDFDA UDI
- Basic UDI-DI
- 888501461iSRobot25 EUDAMED
- FDA Product Code
- IYO FDA UDIITX FDA UDILLZ FDA UDIOIJ FDA UDI
- EMDN Code
- Z12169099 VARIOUS INSTRUMENTS FOR UROLOGY - OTHER EUDAMED
- GMDN Term
- Prostate stereotactic biopsy/ablation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1570 FDA UDI892.2050 FDA UDI
- Market of Registration
- Croatia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
iSR'obot Mona Lisa 2.0 by Biobot Surgical Pte. Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 888501461iSRobot25 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 0c2524b7-af1a-429f-ba04-999adc301d61 61 fields · synced Jun 18, 2026
- FDA UDI c40a5a4a-99f7-4f25-ba42-dfbff33b3671 32 fields · synced May 30, 2026