Taiwan FDA registration 44439a7641bd2a7e43a4f07732d23e2c

Roche Speedan Blood Pen (unsterilized)

TW: 羅氏速讚採血筆(未滅菌)
Taiwan flagTaiwan·Risk Class 1·Roche Diabetes Care GmbH;; Balda Medical GmbH·Registered Oct 14, 2022 – Oct 14, 2027Active
Registration details
Analysis ID
44439a7641bd2a7e43a4f07732d23e2c
Customs Code
DHA09402292202
Company information
Manufacturer Country
Germany
Authorized Representative
ROCHE DIAGNOSTICS LTD.
Product details
Intended Use
Limited to the first level identification scope of the "Manual Instruments for General Surgery (I.4800)" of the Measures for the Classification and Grading Management of Medical Equipment.
Product Type (Level 1)
I General, Plastic Surgery and Dermatology
Product Type (Level 2)
I.4800 Hand Instruments for General Surgery
Import Information
委託製造;; QMS/QSD;; 輸入
Dates and status
Registration Date
Oct 14, 2022
Expiry Date
Oct 14, 2027
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About this record

Access comprehensive regulatory information for Roche Speedan Blood Pen (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 44439a7641bd2a7e43a4f07732d23e2c and manufactured by Roche Diabetes Care GmbH;; Balda Medical GmbH. The authorized representative in Taiwan is ROCHE DIAGNOSTICS LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including ROCHE DIABETES CARE GMBH, and 1 recent registrations in the same category. 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.

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