South Korea MFDS registration Reception No. 21-1815
Reusable manual medical opening device
KO: 재사용가능수동식의료용개창기구
Basic information
- Item Serial Number
- 2021005361
- License Number
- Reception No. 21-1815
- Classification Number
- A56010.01(1)
- Device Class (Risk Classification)
- Class I
- Classification Name
- Reusable manual medical opening device
- Official English Name
- Retractor, surgical, manually-operated
수신21-1815호
재사용가능수동식의료용개창기구
Company information
- Entity Address
- 서울특별시 영등포구 국제금융로8길 27-9 1010호(여의도동,동북빌딩)
- Manufacturer
- Katena Products, Inc.
- Category
- Import business
- Business License Number
- 제 110 호
수입업
Important dates & status
- Item Approval Date
- Sep 29, 2021
- Business Permit Date
- Oct 20, 2004
- Expiration Period
- 2021-09-29 ~ 2026-09-28
- For Export
- 아니오
Model information
- Model Name
- AE-2562 and 7 other cases
AE-2562외 7건
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. 21-1815. Approved on Sep 29, 2021. Registered by Sungwoo Medical Co., Ltd..
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