| Device Name: |
Clinical Laserthermia Systems TRANBERG Thermal Therapy System [Clinical Laserthermia Systems AB] |
| Description: |
The TRANBERG Mobile Laser Unit is intended for thermal ablation of soft tissue pathological lesions. The device is intended to be used by trained medical health care professionals in hospitals or in outpatient clinics. It can be used for tumor control and/or symptomatic relief and/or restoring of physiological functions when other treatment options are not eligible or effective: • In the liver for thermal ablation of soft tissue pathological lesions (tumors) in adults • In the prostate for thermal ablation of soft tissue pathological lesions (localized low or intermediate risk prostate cancer with significant life expectancy or benign prostate hyperplasia, BPH) in adults. |
| Medical Specialty Area: |
Radiology / Imaging
|
| Medical Device Class: |
Class C medical device
|
| Device Registration No: |
DE0508805
|
| Registration Date: |
03/01/2024
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| Change Notification Approval Date: |
Not Applicable
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| Device System Info: |
[System or Procedure Pack], [Sterile Medical Device], System consisted of laser unit, thermoguide and accessories. Accessories (Applicators, Introducers and Temperature probes) are sterile (Ethylene Oxide). |
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| No. |
Model Name |
Identifier |
UDI-DI |
DM-DI |
Place of Manufacture |
| 1 | Laser Applicator Non-cooled | 4012-01 | | | GERMANY, ITALY | | 2 | Laser Applicator Non-cooled | 4012-05 | | | GERMANY, ITALY | | 3 | Laser Applicator Non-cooled | 4017-01 | | | GERMANY, ITALY | | 4 | Laser Applicator Non-cooled | 4017-02 | | | GERMANY, ITALY | | 5 | Laser Applicator Non-cooled | 4017-03 | | | GERMANY, ITALY | | 6 | Laser Applicator Non-cooled | 4017-04 | | | GERMANY, ITALY | | 7 | TRANBERG® Tissue Temp Probe | 3001-01 | | | ITALY | | 8 | TRANBERG® Tissue Temp Probe | 3002-01 | | | ITALY | | 9 | TRANBERG® Tissue Temp Probe | 3003-01 | | | ITALY | | 10 | TRANBERG® Tissue Temp Probe | 3004-01 | | | ITALY | | 11 | TRANBERG® Tissue Temp Probe | 3001-02 | | | ITALY | | 12 | TRANBERG® Tissue Temp Probe | 3002-02 | | | ITALY | | 13 | TRANBERG® Tissue Temp Probe | 3003-02 | | | ITALY | | 14 | TRANBERG® Tissue Temp Probe | 3004-02 | | | ITALY | | 15 | Thermoguide Workstation | 1100-01 | | | SWEDEN | | 16 | TRANBERG® Mobile Laser Unit | 1001-02 | | | SPAIN, ITALY | | 17 | TRANBERG® MR Stylet | 4013-08 | | | ITALY, SWEDEN | | 18 | TRANBERG® MR Stylet | 4013-11 | | | ITALY, SWEDEN | | 19 | TRANBERG® MR Stylet | 4013-13 | | | ITALY, SWEDEN | | 20 | TRANBERG® MR Cathater | 4013-10 | | | ITALY, SWEDEN | | 21 | TRANBERG® MR Cathater | 4013-12 | | | ITALY, SWEDEN |
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Note: All device listings on the Singapore Medical Device Register (SMDR) are active. Class A medical devices are not registered in the SMDR. To retrieve Class A medical devices, please visit Class A Medical Device Database.
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