Taiwan FDA registration b9b22dd4bc11af7c1007dbb29ec73f1a

"Elma" Pixer CO2 laser system

TW: “艾兒瑪”皮克瑟二氧化碳雷射系統
Taiwan flagTaiwan·Risk Class 2·Alma Lasers GmbH;; Alma Lasers Ltd.·Registered Aug 01, 2018 – Aug 01, 2028Active
Registration details
Analysis ID
b9b22dd4bc11af7c1007dbb29ec73f1a
Customs Code
DHA05603137700
Company information
Manufacturer Country
Israel;;Germany
Authorized Representative
TBMS INTERNATIONAL CORPORATION
Product details
Intended Use
For details, it is Chinese approved copy of the imitation order
Product Type (Level 1)
I General, Plastic Surgery and Dermatology
Product Type (Level 2)
I.4810 Lasers for general surgical, orthopaedic and dermatological use
Import Information
The use of this device shall comply with the provisions of the "Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing". Contract manufacturing;; input
Dates and status
Registration Date
Aug 01, 2018
Expiry Date
Aug 01, 2028
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About this record

Access comprehensive regulatory information for "Elma" Pixer CO2 laser system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b9b22dd4bc11af7c1007dbb29ec73f1a and manufactured by Alma Lasers GmbH;; Alma Lasers Ltd.. The authorized representative in Taiwan is TBMS INTERNATIONAL CORPORATION.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Alma Lasers GmbH;; Alma Lasers Ltd., 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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