SOMNICS, INC.
萊鎂醫療器材股份有限公司
Leave your email for change alerts (optional)
1Plants
9Certifications
1Patents
< NT$20MRevenue band (est.)
- Unified Business No.
- 25181598
- Industry
- Other Manufacturing (2,432)
- Main products
- Medical devices & supplies (878)
- Location
- 5 F., No. 22, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu County 30261, Taiwan (R.O.C.)
Hsinchu County (1,617) · Zhubei City (468) - Listing
- Not publicly issued (84,625)
- Organisation type
- Company Limited by Shares
- Representative
- Chen Chung-chu
- Phone
- 03-5509623
- Website
- https://www.somnics.com/
- Exporter
- Yes — registered with the Trade Administration
- Annual revenue band
- < NT$20M estimated
- Ownership
- Family-run (inferred)
- North American market
- FDA 510(k) clearance FDA medical device registration
- Representative tenure
- In office since at least 2013 (13+ years)
- Compliance record
- Labour Standards Act penalties: 2 case(s) in 5 years, latest 2026-07-23, fines NT$ 60,000 (Art. 22) — matched by company name
Certifications 9
- Medical device license (Class I) (1,430)Official registry Valid until 2022-04-06 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2022-04-06 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class I) (1,430)Official registry Valid until 2030-03-28 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2027-12-15 · Taiwan Food and Drug Administration (TFDA)
- Medical device license (Class II) (794)Official registry Valid until 2029-10-23 · Taiwan Food and Drug Administration (TFDA)
- CE Marking (162)Self-reported
- GMP (261)Self-reported
- ISO 13485 (310)Self-reported
- ISO 9001 (4,293)Self-reported
Processes & materials 1
- Copper alloy (324) · MetalSelf-reported
Patents 1
- 2024 Nasal dilator with expiratory positive airway pressure valve component, assembly thereof and application thereof
North American market evidence 3
- FDA 510(k) clearance K220907 2023-06-16
The iNAP One Sleep Therapy System - FDA 510(k) clearance K152660 2016-11-09
HYPNOSPAD - FDA medical device registration 3014674517 2020-05-26 – 2024-01-03
Intraoral Pressure Gradient Device; Dilator, Nasal
Recent changes 1
- PenaltiesLabour Standards Act penalties: latest case 2026-07-23; 2 case(s) in 5 years, fines NT$ 60,000
RSS feed · Recent changes at Taiwanese manufacturers →
Similar companies 10
- ROLENCE ENTERPRISE INC. · Taoyuan City NT$20–100M estimated
Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP - FREE BIONICS TAIWAN INC. · Hsinchu City < NT$20M estimated
Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP - OMNIMATE ENTERPRISE CO., LTD. · Yilan County < NT$20M estimated
Shared: Medical device license (Class I), Medical device license (Class II), CE Marking, GMP - WINNOMED COMPANY LTD. · Taoyuan City < NT$20M estimated
Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c. - TAIWAN ONP COMPANY · Taipei City < NT$20M estimated
Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c. - CAREMED SUPPLY INC. · Yilan County NT$20–100M estimated
Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485 - OSSAWARE BIOTECH CO., LTD. · Changhua County < NT$20M estimated
Shared: Medical device license (Class I), Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c. - BIOPTIK TECHNOLOGY, INC. · Hsinchu City Listed (TPEx) NT$0.5–1B
Shared: Copper alloy, Medical device license (Class I), Medical device license (Class II), GMP - Huijia Health Corporation · Hsinchu County < NT$20M estimated
Shared: Medical device license (Class II), Other pharmaceuticals & medical supplies wholesale n.e.c., Other medical devices & supplies manufacturing n.e.c. - PEGAVISION CORPORATION · Taoyuan City Listed (TWSE) ≥ NT$5B
Shared: Medical device license (Class I), Medical device license (Class II), GMP, ISO 13485