Eu Mdd
Eu Md Class 2a
On The Market
🇸🇬 Singapore
VARIOUS INSTRUMENTS FOR UROLOGY - SOFTWARE ACCESSORIES
Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1
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Basic Information
- Primary DI
- D-G4AS091LU
- Basic UDI-DI Code
- B-G4AS091LU
- Reference
- iSR'obot MRI-US Fusion
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Biobot Surgical Pte Ltd
Additional Description
The iSR’obot MRI-US Fusion is a software application to be used by Clinicians in the clinic or hospital for 2-D and 3-D visualisation, image registration, and fusion of Magnetic Resonance and Ultrasound images for mapping planning information of the prostate gland and region of interest.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12169082 | VARIOUS INSTRUMENTS FOR UROLOGY - SOFTWARE ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 603229 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
🇩🇪 Germany
🇮🇹 Italy
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