Vietnam MOH registration 240001615/PCBB-HCM

Continuous Blood Pressure Monitoring Device with Accessories (C601.105, C601.107, C601.106, C601.104)

VN: Máy theo dõi huyết áp liên tục kèm phụ kiện (bao đo huyết áp C601.105, C601.107, C601.106, C601.104)

Vietnam·Risk Class TTBYT Loại B·BTL-08 ABPM·BTL lndustries Limited·Registered Jul 29, 2024

Registration details

Analysis ID: 240001615/PCBB-HCM
Submission ID: 000.00.19.H29-240722-0003
Product Type: BTL-08 ABPM
Product Code: BTL-08 ABPM

Company information

Manufacturer: BTL lndustries Limited
Manufacturer Country: Theo theo phụ lục
Product Owner: BTL lndustries Limited
Authorized Representative: CÔNG TY TNHH BTL VIỆT NAM

Technical details

Intended Use: Continuous blood pressure monitoring, used in the diagnosis of the following conditions: • White coat hypertension. • Nocturnal hypertension. • To establish hypotension state. • Refractory hypertension. • Use in elderly patients. • As a guide to antihypertensive drug therapy. • Type 1 diabetes. • Gestational hypertension, including preeclampsia. • Evaluation of hypotension status. • Autonomic neuropathy.

Dates and status

Registration Date: Jul 29, 2024

About this record

Access comprehensive regulatory information for Continuous Blood Pressure Monitoring Device with Accessories (C601.105, C601.107, C601.106, C601.104) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001615/PCBB-HCM and manufactured by BTL lndustries Limited. The authorized representative in Vietnam is CÔNG TY TNHH BTL VIỆT NAM.

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