Taiwan FDA registration 06e632062143563953e08ce2b30eb5c1

Roche Solid Blood Collection Pen (unsterilized)

TW: 羅氏可固全專用採血筆(未滅菌)
Taiwan flagTaiwan·Risk Class 1·Roche Diabetes Care GmbH;; Balda Medical GmbH·Registered Dec 02, 2022 – Dec 02, 2027Active
Registration details
Analysis ID
06e632062143563953e08ce2b30eb5c1
Customs Code
DHA09402297204
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
QMS/QSD;; 輸入;; 委託製造
Dates and status
Registration Date
Dec 02, 2022
Expiry Date
Dec 02, 2027
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About this record

Access comprehensive regulatory information for Roche Solid Blood Collection 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 06e632062143563953e08ce2b30eb5c1 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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