Medical Device Division · registration 100189ExpiredMedinol
Hong KongStents, Biliary, Metallic, Self-ExpandingClass IIIMedinol Ltd.
Official record identity
- MDACS listing number
- 100189
- Model name
- X-Suit NIR Biliary Metallic Stent (SME-200P-08040, SME-200P-08060, SME-200P-08080, SME-200P-08100, SME-200P-10040, SME-200P-10060, SME-200P-10080, SME-200P-10100), X-Suit NIR Covered Biliary Metallic Stent (SME-210P-08060, SME-210P-08080, SME-210P-10060, SME-210P-10080)
- Registration date
- June 25, 2015
- Expiry date
- June 25, 2020
- Source update date
- November 26, 2025
- Status
- Expired
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Olympus Hong Kong and China Limited
- Manufacturer
- Medinol Ltd.
Official description
Stents, Biliary, Metallic, Self-Expanding
Additional source fields
- AMD nomenclature code
- 20421
- Local responsible person phone
- 21705678
- Published manufacturer address
- PO Box 45026, Beck Tech Bldg. Har-Hotzvim B, Hartom Street 8, Jerusalem 9777508, Israel
- Published remarks
- Expired.
- Revision number
- a
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.