Taiwan FDA registration b3a2d21b82b4039ca8a133473793421a

"Sandek" otoscope (unsterilized)

TW: "桑得克" 耳鏡 (未滅菌)

Taiwan·Risk Class 1·SOMETECH INC.·Registered Dec 28, 2005 – Dec 28, 2015Cancelled

Registration details

Analysis ID: b3a2d21b82b4039ca8a133473793421a
Customs Code: DHA04400239207

Company information

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

Product details

Intended Use: It is a device that uses magnification to observe the external auditory canal and eardrum. Alternating current generates a light source and a light amplification system to provide illumination to view the external auditory canal.
Product Type (Level 1): G ENT Science
Product Type (Level 2): G.4770 Ear Mirrors
Import Information: import

Dates and status

Registration Date: Dec 28, 2005
Expiry Date: Dec 28, 2015
Cancellation Date: Aug 13, 2018

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Sandek" otoscope (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b3a2d21b82b4039ca8a133473793421a and manufactured by SOMETECH INC.. The authorized representative in Taiwan is MEDWAY BME CORPORATION.

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