South Korea MFDS registration Reception No. 21-1828

Reusable manual medical opening device

KO: 재사용가능수동식의료용개창기구
South Korea flagSouth Korea·Class I·Sungwoo Medical Co., Ltd.·Approved Oct 05, 2021
Basic information
Item Serial Number
2021005425
License Number
Reception No. 21-1828
수신21-1828호
Classification Number
A56010.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Reusable manual medical opening device
재사용가능수동식의료용개창기구
Official English Name
Retractor, surgical, manually-operated
Company information
Entity Name (Company)
Sungwoo Medical Co., Ltd.
(주)성우메디칼
Entity Address
서울특별시 영등포구 국제금융로8길 27-9 1010호(여의도동,동북빌딩)
Manufacturer
Katena Products Inc.
Category
Import business
수입업
Business License Number
제 110 호
Important dates & status
Item Approval Date
Oct 05, 2021
Business Permit Date
Oct 20, 2004
Expiration Period
2021-10-05 ~ 2026-10-04
For Export
아니오
Model information
Model Name
AE-2323 and 19 other cases
AE-2323외 19건
About this record

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number Reception No. 21-1828. Approved on Oct 05, 2021. Registered by Sungwoo Medical Co., Ltd..

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