Taiwan FDA registration 6d145445f16f9fb64c8d0d731b58411d

"Seyck" Spai laparoscope

TW: “史賽克”斯拜腹腔鏡

Taiwan·Risk Class 2·Qingdao O-Mec Medical Technology Co., LTD;; STRYKER ENDOSCOPY·Registered Mar 12, 2024 – Mar 12, 2029Active

Registration details

Analysis ID: 6d145445f16f9fb64c8d0d731b58411d
Customs Code: DHA09200155000

Company information

Manufacturer: Qingdao O-Mec Medical Technology Co., LTD;; STRYKER ENDOSCOPY
Manufacturer Country: United States;;China
Authorized Representative: Stryker (Far East) Co., Ltd. Taiwan Branch

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): H Gastroenterology and urology
Product Type (Level 2): H.1500 Internal Scope and its accessories
Import Information: Contract manufacturing;; Chinese goods;; input

Dates and status

Registration Date: Mar 12, 2024
Expiry Date: Mar 12, 2029

About this record

Access comprehensive regulatory information for "Seyck" Spai laparoscope in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6d145445f16f9fb64c8d0d731b58411d and manufactured by Qingdao O-Mec Medical Technology Co., LTD;; STRYKER ENDOSCOPY. The authorized representative in Taiwan is Stryker (Far East) Co., Ltd. Taiwan Branch.

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