Vietnam MOH registration 240001417/PCBB-HCM

12-Channel ECG Monitor with Accessories (V2 Headgear for face mask 7450, size ES/P)

VN: Máy đo điện tim 12 kênh kèm phụ kiện (mặt nạ thở V2 Headgear for face mask 7450, size ES/P)

Vietnam·Risk Class TTBYT Loại B·BTL Flexi 12 ECG·BTL Industries JSC·Registered Jul 08, 2024

Registration details

Analysis ID: 240001417/PCBB-HCM
Submission ID: 000.00.19.H29-240702-0013
Product Type: BTL Flexi 12 ECG
Product Code: BTL Flexi 12 ECG

Company information

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

Technical details

Intended Use: Measurement and Diagnosis of Cardiovascular Diseases

Dates and status

Registration Date: Jul 08, 2024

About this record

Access comprehensive regulatory information for 12-Channel ECG Monitor with Accessories (V2 Headgear for face mask 7450, size ES/P) 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 240001417/PCBB-HCM and manufactured by BTL Industries JSC. The authorized representative in Vietnam is CÔNG TY TNHH BTL VIỆT NAM.

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