Medical Device Division · registration 230168ActiveEDAP TMS France
Hong KongUltrasound Therapy Systems, Tissue AblationClass IIIEDAP TMS France
Official record identity
- MDACS listing number
- 230168
- Model name
- FocalPak Endo (TMS 252833), Focal One (TMS 234780), Endorectal Probe (TMS 902000, TMS 902081, TMS 253728), FocalPak (EDP 901400)
- Registration date
- June 24, 2026
- Expiry date
- May 09, 2028
- Source update date
- June 30, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Qualtech Consulting Corporation Ltd.
- Manufacturer
- EDAP TMS France
Official description
Ultrasound Therapy Systems, Tissue Ablation
Additional source fields
- AMD nomenclature code
- 18825
- Local responsible person phone
- 63412255
- Published manufacturer address
- Parc d'Activités La Poudrette Lamartine - 4 rue du Dauphiné - 69120 VAULX-EN-VELIN, FRANCE
- Revision number
- a
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.