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HSA · registration DE0510340

BRATTEA MedTech Netrod Renal Denervation Radiofrequency System

SingaporeCardiovascularClass CBRATTEA MedTech Co., Ltd
Official record identity
Registration number
DE0510340
Model name
Netrod™ Renal Denervation Radiofrequency Generator; Netrod™ G2 Renal Denervation Radiofrequency Generator; Netrod™️ Six-Electrode Basket Radiofrequency Renal Denervation Catheter; Netrod™️ Six-Electrode Basket Radiofrequency Renal Denervation Catheter
Model identifier
GL-06E15W A; GL-06E15W B; GL-6W 12mm; GL-6W 8mm
Registration date
February 14, 2025
Source update date
November 26, 2025
Classification
Risk class
Class C
Official value: CLASS C
Published category
Cardiovascular
Published parties
Registrant / registration holder
ANDAMAN MEDICAL PTE. LTD.
Official description

Netrod Renal Denervation Radiofrequency System is used in percutaneous renal sympathetic denervation procedures. Netrod Renal Denervation Radiofrequency System is indicated for patients aged ≥18 years with uncontrolled primary hypertension [office BP ≥ 150/90 and <180/110 mmHg and mean 24 h ambulatory systolic BP (SBP) ≥135 mmHg] despite being on stable anti-hypertensive medication regime and standardized antihypertensive therapy.

Additional source fields
Product owner address
Room 202, Building 4, No.138 Xinjunhuan Road, Minhang District, Shanghai, 201114, China
Registrant address
300 TAMPINES AVENUE 5, #09-02, INCOME AT TAMPINES JUNCTION, Singapore 529653
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.