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iSR'obot MRI-US Fusion
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref iSR'obot MRI-US Fusion510(k) K161109
Identity
- Device Name
- iSR'obot MRI-US Fusion EUDAMED
- Model / Reference
- iSR'obot MRI-US Fusion EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-G4AS091LU EUDAMED
- Basic UDI-DI
- B-G4AS091LU EUDAMED
- EMDN Code
- Z12169082 VARIOUS INSTRUMENTS FOR UROLOGY - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
iSR'obot MRI-US Fusion by Biobot Surgical Pte. Ltd. — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161109 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-G4AS091LU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Biobot Surgical Pte Ltd
- EUDAMED SRN
- SG-MF-000020631
- FDA Applicant
- Biobot Surgical Pte., Ltd.
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 42654bbf-dd5d-4ad6-be0b-f1c26a26b863 85 fields · synced Jun 18, 2026
- FDA 510(k) K161109 1 fields · synced May 18, 2026