EU Manufacturer
๐จ๐ฆ Canada
Active
bioLytical Laboratories Inc.
SRN: CA-MF-000023304
ยท
406-13251 Delf Place, V6V 2A2 Richmond, Canada
Basic UDI-DIs
38
Total Devices
38
On Market
38
Off Market
0
Certificates
5
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- 406-13251 Delf Place, V6V 2A2 Richmond, Canada
- [email protected]
- Phone
- +16042046784 ext 262
Regulatory Overview
Regulation
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Eu Ivdd
38
Classification
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Eu Ivd Annex 2 List A
34
Eu Ivd General
4
Device Types
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Certificate Health
Total
5
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
5
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | DGM-549 | Presafe Denmark A/S | May 26, 2024 | |||
| IVDD Annex IV Section 4 | DGM-548 | Presafe Denmark A/S | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | DGM-0549 | Presafe Denmark A/S | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | DGM-459 | Presafe Denmark A/S | May 26, 2024 | |||
| IVDD Annex IV Section 4 | DGM-458 | Presafe Denmark A/S | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| INSTI COVID ANTIBODY TEST | EU IVDD | Eu Ivd General | On Market | 0 |
| INSTI HCV CONTROL TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HCV ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HCV ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HCV ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HCV ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HCV ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV ANTIBODY SELF-TEST | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV Self Test | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 ANTIBODY TEST KIT | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 Antibody Test | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI HIV-1/HIV-2 Control Test | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI Multiplex Test Kit | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI Multiplex Test Kit | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI Multiplex Test Kit | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI Multiplex Test Kit | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI Multiplex Test Kit | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI Multiplex Test Kit | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| INSTI Multiplex Test Kit | EU IVDD | Eu Ivd Annex 2 List A | On Market | 2 |
| iSTATIS COVID-19 Ag HOME TEST | EU IVDD | Eu Ivd General | On Market | 0 |
| iSTATIS COVID-19 Ag HOME TEST | EU IVDD | Eu Ivd General | On Market | 0 |
| iSTATIS COVID-19 Ag TEST | EU IVDD | Eu Ivd General | On Market | 0 |