Taiwan FDA registration d0c7bf3b2712dc0a2944467ae947f673

"Assula" needle sleeve (sterilized)

TW: “艾塑亞”針頭套組(滅菌)

Taiwan·Risk Class 2·Yurim Medical Co., Ltd.;; Oreon Life Science Co., Ltd.·Registered Jul 15, 2022 – Jul 15, 2027Active

Registration details

Analysis ID: d0c7bf3b2712dc0a2944467ae947f673
Customs Code: DHA05603552901

Company information

Manufacturer: Yurim Medical Co., Ltd.;; Oreon Life Science Co., Ltd.
Manufacturer Country: Korea, Republic of
Authorized Representative: MEGAMEDI International Ent. Co., Ltd.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): J General hospital and personal use equipment
Product Type (Level 2): J.5570 Subcutaneous single-chamber needle
Import Information: Contract manufacturing;; input

Dates and status

Registration Date: Jul 15, 2022
Expiry Date: Jul 15, 2027

About this record

Access comprehensive regulatory information for "Assula" needle sleeve (sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d0c7bf3b2712dc0a2944467ae947f673 and manufactured by Yurim Medical Co., Ltd.;; Oreon Life Science Co., Ltd.. The authorized representative in Taiwan is MEGAMEDI International Ent. Co., Ltd..

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