Taiwan FDA registration 48d81d84fda5e37048c1fe6749ca2fe7

"Sandek" surgical camera and its accessories (unsterilized)

TW: "桑得克" 外科手術用照相機及其附件 (未滅菌)

Taiwan·Risk Class 1·SOMETECH INC.·Registered Apr 20, 2011 – Apr 20, 2021Cancelled

Registration details

Analysis ID: 48d81d84fda5e37048c1fe6749ca2fe7
Customs Code: DHA04401023207

Company information

Manufacturer: SOMETECH INC.
Manufacturer Country: Korea, Republic of
Authorized Representative: MEDWAY BME CORPORATION

Product details

Intended Use: Limited to the first level of identification scope of the Measures for the Administration of Medical Devices "Surgical Cameras and Their Accessories (I.4160)".
Product Type (Level 1): I General, Plastic Surgery and Dermatology
Product Type (Level 2): I.4160 Surgical cameras and accessories thereof
Import Information: import

Dates and status

Registration Date: Apr 20, 2011
Expiry Date: Apr 20, 2021
Cancellation Date: Aug 28, 2023

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Sandek" surgical camera and its accessories (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 48d81d84fda5e37048c1fe6749ca2fe7 and manufactured by SOMETECH INC.. The authorized representative in Taiwan is MEDWAY BME CORPORATION.

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