Medical Device Division · registration 180027ActiveTaewoong Medical
Hong KongStents, Biliary, Metallic, Self-ExpandingClass IIITaewoong Medical Co., Ltd.
Official record identity
- MDACS listing number
- 180027
- Model name
- Niti-S Biliary Covered Stent (Full Covered-type/ Endoscopic Introducer) (BS0603F, BS0604F, BS0605F, BS0606F, BS0607F, BS0608F, BS0609F, BS0610F, BS0612F, BS0803F, BS0804F, BS0805F, BS0806F, BS0807F, BS0808F, BS0809F, BS0810F, BS0812F, BS1003F, BS1004F, BS1005F, BS1006F, BS1007F, BS1008F, BS1009F, BS1010F, BS1012F)
- Registration date
- September 20, 2024
- Expiry date
- February 20, 2028
- Source update date
- October 09, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Medi-Technic Group Limited
- Manufacturer
- Taewoong Medical Co., Ltd.
Official description
Stents, Biliary, Metallic, Self-Expanding
Additional source fields
- AMD nomenclature code
- 20421
- Traditional Chinese local responsible person
- 鵠志醫療有限公司
- Local responsible person phone
- 39132193
- Published manufacturer address
- 14 Gojeong-ro, Wolgot-myeon, Gimpo-si, Gyeonggi-do, Korea
- Revision number
- b
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.