EU Manufacturer
🇹🇼 Taiwan
Active
General Biologicals Corporation
SRN: TW-MF-000024694
·
#6, Innovation First Road, Hsinchu Science Park, Baoshan Township, 300 Hsinchu County , Taiwan
Basic UDI-DIs
13
Total Devices
13
On Market
13
Off Market
0
Certificates
12
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- #6, Innovation First Road, Hsinchu Science Park, Baoshan Township, 300 Hsinchu County , Taiwan
- [email protected]
- Phone
- +886 3 557-9221
Regulatory Overview
Regulation
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Eu Ivdd
13
Classification
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Eu Ivd Annex 2 List A
13
Device Types
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Certificate Health
Total
12
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
12
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE02 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE08 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE01 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE02 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE09 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE06 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE04 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE10 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE03 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE07 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV (excluding sections 4, 6) | 2116030CE04 | DEKRA Certification B.V. | May 26, 2025 | |||
| IVDD Annex IV Section 4 | 2116030DE11 | DEKRA Certification B.V. | May 26, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ANTICORASE B-96 (TMB) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 1 |
| ANTICORASE MB-96 (TMB) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ANTISURASE B-96 (TMB) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ANTISURASE B-96 II (TMB) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| ANTISURGEN B | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| EASE BN-96 (TMB) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| GB HIV Ag-Ab COMB | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| GB HIV Ag-Ab COMB | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| HBV RealQuant™ PCR | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| NANBASE C-96 V4.0 | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| NANBASE C-96 V4.0 | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| SURASE B-96 (TMB) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| SURASE B-96 (TMB) | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |