Medical Device Division · registration 180028ActiveTaewoong Medical
Hong KongStents, Biliary, Metallic, Self-ExpandingClass IIITaewoong Medical Co., Ltd.
Official record identity
- MDACS listing number
- 180028
- Model name
- Niti-S Biliary Covered Stent (Both Bare-type / Endoscopic Introducer) (BS0604B, BS0605B, BS0606B, BS0607B, BS0608B, BS0609B, BS0610B, BS0612B, BS0804B, BS0805B, BS0806B, BS0807B, BS0808B, BS0809B, BS0810B, BS0812B, BS1004B, BS1005B, BS1006B, BS1007B, BS1008B, BS1009B, BS1010B, BS1012B)
- 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.