EU Manufacturer
🇹🇼 Taiwan
Active
Somnics, Inc.
SRN: TW-MF-000009441
·
5F, No.22, Sec.2, Sheng Yi Rd., Hsinchu Science Park, 30261 Zhubei City, Hsinchu County, Taiwan
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Watch Somnics, Inc. for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- 5F, No.22, Sec.2, Sheng Yi Rd., Hsinchu Science Park, 30261 Zhubei City, Hsinchu County, Taiwan
- [email protected]
- Phone
- +886 3 5509623
- Website
- https://www.somnics.com/
Regulatory Overview
Regulation
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Eu Mdr
3
Eu Mdd
2
Classification
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Eu Md Class 1
3
Eu Md Class 2a
2
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | TW19/20030 | SGS Belgium NV | Apr 11, 2023 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| iNAP | EU MDR | Eu Md Class 1 | On Market | 0 |
| iNAP | EU MDD | Eu Md Class 2a | On Market | 1 |
| iNAP | EU MDD | Eu Md Class 2a | On Market | 1 |
| iNAP Saliva Container | EU MDR | Eu Md Class 1 | On Market | 0 |
| iNAP Tubing Set | EU MDR | Eu Md Class 1 | On Market | 0 |