Medical Device Division · registration 240043ActiveInspire Medical Systems
Hong KongStimulators, Electrical Neuromuscular, Obstructive Sleep Apnea, ImplantableClass IVInspire Medical Systems, Inc.
Official record identity
- MDACS listing number
- 240043
- Model name
- Inspire IV Implantable Pulse Generator, Model 3028, Inspire Sensing Lead, Model 4340, Inspire Stimulation Lead, Model 4063, Inspire Programmer, Model 2740, Inspire Sleep Remote, Model 2500, Inspire Sleep Remote, Model 2580
- Registration date
- February 19, 2024
- Expiry date
- February 18, 2029
- Source update date
- April 25, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class IV
- Published category
- Stimulators, Electrical Neuromuscular, Obstructive Sleep Apnea, Implantable
Official value: IV
Published parties
- Registrant / registration holder
- Synapse Therapeutics Limited
- Manufacturer
- Inspire Medical Systems, Inc.
Official description
Stimulators, Electrical Neuromuscular, Obstructive Sleep Apnea, Implantable
Additional source fields
- AMD nomenclature code
- 33843
- Traditional Chinese local responsible person
- 百谷醫療科技有限公司
- Local responsible person phone
- 31881638
- Published manufacturer address
- 5500 Wayzata Blvd, Suite 1600, Golden Valley, Minnesota 55416, USA
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.