Taiwan FDA registration 39d7556a5e236e7d5f4693813fdb1b7f

Accu-Chek Active test strips

TW: 羅氏活力血糖機專用試紙

Taiwan·Risk Class 2·MD·ROCHE DIABETES CARE GMBH·Registered Sep 11, 2014 – Sep 11, 2024Expired

Registration details

Analysis ID: 39d7556a5e236e7d5f4693813fdb1b7f
License Form: Ministry of Health Medical Device Import No. 026524
Customs Code: DHA05602652403

Company information

Manufacturer: ROCHE DIABETES CARE GMBH
Manufacturer Country: Germany
Authorized Representative: ROCHE DIAGNOSTICS LTD.

Product details

Intended Use: Performance (discretionary) change: The test strip and its special blood glucose machine are suitable for quantitative detection of blood glucose in fresh fingertip microvascular, venous, arterial and neonatal blood. Suitable for blood glucose self-testing in diabetic patients and testing by professionals. This product is paired with the Accue-Chek Active blood glucose machine. Professionals may also test venous, arterial, and neonatal blood containing heparin lithium, heparin ammonia, or EDTA anticoagulants.
Product Type (Level 1): A Clinical chemistry and clinical toxicology
Product Type (Level 2): A1345 Glucose Test System
Import Information: Imported from abroad

Dates and status

Registration Date: Sep 11, 2014
Expiry Date: Sep 11, 2024

About this record

Access comprehensive regulatory information for Accu-Chek Active test strips in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 39d7556a5e236e7d5f4693813fdb1b7f and manufactured by ROCHE DIABETES CARE GMBH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.