190095
II
current
Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Tongue Retaining咬合夹板、阻塞性睡眠呼吸暂停/抗打鼾、舌头潴留
This profile provides complete Hong Kong MDACS registration information for Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Tongue Retaining. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Tongue Retaining
產品資訊： 咬合夹板、阻塞性睡眠呼吸暂停/抗打鼾、舌头潴留
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
II
Product Code
30213
Product Code Detail
30213 Occlusal Splints, Obstructive Sleep Apnea/Anti-Snoring, Tongue Retaining
State
current
Status
N/A
Manufacturer (製造商)
Somnics, Inc.
Somnics, Inc.
Taiwan
台湾
5F, No.22, Sec.2, Sheng Yi Rd., Hsinchu Science Park, Zhubei City, Hsinchu County, 30261, Taiwan
新竹科学园区盛义路二段 22 号 5 楼, 竹北市, 新竹县, 30261, 台湾
Authorised Representative (AR)
Regulatory Timeline
Registration Date
May 22, 2024
Expiry Date
March 28, 2029
Product Models
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)
iNAP Lite 睡眠治疗系统(NP-R03-K、NP-R03-K02、NP-R03-K02S、NP-R03-K03、NP-R03-K03S)、iNAP One 睡眠治疗系统(NP-R07、NP-R07-B93A、NP-R07-B94A、NP-R07-P9CA、NP-R07-A)、iNAP 接口套件(K01、K02、K02S、K03、K03S)、iNAP 口服接口(I07、I07M、I07MT、I07S、I07M1、I02S、I02C、I07H、I07L1、I08)