EU Manufacturer
🇹🇼 Taiwan
Active
OK biotech co., Ltd
SRN: TW-MF-000028031
·
No. 91, Sec. 2, Gongdao 5th Rd, 30070 Hsinchu City, Taiwan
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- No. 91, Sec. 2, Gongdao 5th Rd, 30070 Hsinchu City, Taiwan
- [email protected]
- Phone
- +886 3 5160258
- Website
- https://www.okbiotech.com/
Regulatory Overview
Regulation
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Eu Ivdd
1
Classification
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Eu Ivd Annex 2 List B
1
Device Types
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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Expired / Withdrawn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 | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 063505 0063 | TÜV SÜD Product Service GmbH | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Solus V2 Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |