Medical Device Division · registration 230434ActiveArcRoyal
Hong KongNeedles, Catheter IntroductionClass IIArcRoyal
Official record identity
- MDACS listing number
- 230434
- Model name
- Coronary Guidewire Introducer Needle (12-004924, 12-004943, 12-004925, 12-002069)
- Registration date
- November 22, 2023
- Expiry date
- November 22, 2028
- Source update date
- December 19, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Emergo Hong Kong Limited
- Manufacturer
- ArcRoyal
Official description
Needles, Catheter Introduction
Additional source fields
- AMD nomenclature code
- 20244
- Traditional Chinese local responsible person
- 埃默高香港有限公司
- Local responsible person phone
- 22769196
- Published manufacturer address
- Virginia Road, Kells, Co. Meath, Ireland
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.