Taiwan FDA registration af13f69ab506fbff1e8930f4f115e8bf

"K-scope" Operating handlamp (Non-Sterile)

TW: "鎧斯" 手術用頭燈 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·K-SCOPE·Registered Jun 15, 2017 – Jun 15, 2027Active
Registration details
Analysis ID
af13f69ab506fbff1e8930f4f115e8bf
License Form
Ministry of Health Medical Device Import No. 017965
Customs Code
DHA09401796500
Company information
Manufacturer
K-SCOPE
Manufacturer Country
Korea, Republic of
Authorized Representative
Neumbow Technology Co., Ltd
Product details
Intended Use
Limited to the first level identification range of the Measures for the Administration of Medical Devices "Surgical Headlamps (M.4335)".
Product Type (Level 1)
M Ophthalmic devices
Product Type (Level 2)
M4335 Surgical headlamp
Import Information
Imported from abroad
Dates and status
Registration Date
Jun 15, 2017
Expiry Date
Jun 15, 2027
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About this record

Access comprehensive regulatory information for "K-scope" Operating handlamp (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number af13f69ab506fbff1e8930f4f115e8bf and manufactured by K-SCOPE. The authorized representative in Taiwan is Neumbow Technology Co., Ltd.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including K-SCOPE, 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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