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Taiwan·TW-MF-000009441
Last updated September 17, 2026
Information
- Country
- Taiwan
- Address
- 5F, No.22, Sec.2, Sheng Yi Rd., Hsinchu Science Park, Zhubei City, Hsinchu County, Taiwan
- Website
- www.somnics.com/
- —
- —
- [email protected]
- Phone
- +886 3 5509623
- PRRC Contact
- Chieh-Neng Young
- EUDAMED SRN
- TW-MF-000009441
- FDA FEI Number
- 3014674517
- DUNS Number
- 657169335
Catalogue (34)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iNAP One | Starter Kit | FDA UDI | Class II | Active |
| iNAP One | Quarterly Set w/I07 | FDA UDI | Class II | Active |
| iNAP One | P01 | FDA UDI | Class II | Active |
| iNAP | 23000-01 | FDA UDI | Class II | Active |
| Somnics | iBreath | FDA UDI | Class II | Active |
| iNAP | Starter Kit | FDA UDI | Class II | Active |
| iNAP | A03 | FDA UDI | Class II | Active |
| Somnics | ZeeBud | FDA UDI | Class I | Active |
| iNAP One | Starter Kit | FDA UDI | Class II | Active |
| iNAP | Starter Kit | FDA UDI | Class II | Active |
| Somnics | ZeeBud | FDA UDI | Class I | Active |
| iNAP | 22000-07 | FDA UDI | Class II | Active |
| iNAP | 21000-03 | FDA UDI | Class II | Active |
| Somnics | ZeeBud Plus | FDA UDI | Class I | Active |
| iNAP | R07-A | FDA UDI | Class II | Active |
| iNAP | 24000-7S | FDA UDI | Class II | Active |
| Somnics | ZEEPAP | FDA UDI | Class I | Active |
| iNAP | 91000-07 | FDA UDI | Class II | Active |
| iNAP One | Quarterly Set w/I07S | FDA UDI | Class II | Active |
| iNAP | 24000-7H | FDA UDI | Class II | Active |
| iNAP One | Quarterly Set w/I07H | FDA UDI | Class II | Active |
| iNAP | 81000-07 | FDA UDI | Class II | Active |
| iNAP One | Quarterly Kit | FDA UDI | Class II | Active |
| iNAP | R07-B | FDA UDI | Class II | Active |
| iNAP | 28001-07 | FDA UDI | Class II | Active |
| iNAP | I02C | FDA UDI | Class II | Active |
| iNAP One | Quarterly Kit | FDA UDI | Class II | Active |
| iNAP Tubing Set | 23000 | EUDAMED | Class I | Active |
| The iNAP One Sleep Therapy System | K220907 | FDA 510(k) | Class II | Active |
| Hypnospad | K152660 | FDA 510(k) | Class II | Active |
| iNAP | 91000 | EUDAMED | Class IIa | Active |
| iNAP | 21000 | EUDAMED | Class I | Active |
| iNAP | 24000-07 | EUDAMEDFDA UDI | Class IIa | Active |
| iNAP Saliva Container | 22000 | EUDAMED | Class I | Active |
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