Medical Device Division · registration 190095ActiveSomnics
Hong KongOcclusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Tongue RetainingClass IISomnics, Inc.
Official record identity
- MDACS listing number
- 190095
- Model name
- iNAP Lite Sleep Therapy System (NP-R03-K, NP-R03-K02, NP-R03-K02S, NP-R03-K03, NP-R03-K03S), iNAP One Sleep Therapy System (NP-R07, NP-R07-B93A, NP-R07-B94A, NP-R07-P9CA, NP-R07-A), iNAP Interface Kit (K01, K02, K02S, K03, K03S), iNAP Oral Interface (I07, I07M, I07MT, I07S, I07M1, I02S, I02C, I07H, I07L1, I08)
- Registration date
- May 22, 2024
- Expiry date
- March 28, 2029
- Source update date
- June 12, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
- Published category
- Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Tongue Retaining
Official value: II
Published parties
- Registrant / registration holder
- Qualtech Consulting Corporation Ltd.
- Manufacturer
- Somnics, Inc.
Official description
Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Tongue Retaining
Additional source fields
- AMD nomenclature code
- 30213
- Local responsible person phone
- 63412255
- Published manufacturer address
- 5F, No.22, Sec.2, Sheng Yi Rd., Hsinchu Science Park, Zhubei City, Hsinchu County, 30261, Taiwan
- 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.