EU Manufacturer
๐ซ๐ฎ Finland
Active
Wallac Oy
SRN: FI-MF-000022620
ยท
Mustionkatu 6, FI-20750 Turku, Finland
Basic UDI-DIs
147
Total Devices
156
On Market
145
Off Market
11
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Mustionkatu 6, FI-20750 Turku, Finland
- [email protected]
- Phone
- +3582 2678111
- Website
- www.revvity.com
Regulatory Overview
Regulation
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Eu Ivdd
110
Eu Ivdr
37
Classification
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Eu Ivd General
62
Eu Ivd Annex 2 List B
48
Eu Ivd Class A
37
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Expired / Withdrawn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) | C-02-1088-787-22 | Eurofins Electric & Electronics Finland Oy | Oct 29, 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 | ||||
|---|---|---|---|---|
| AutoDELFIA Free hCGร | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| AutoDELFIA Immunoassay Screening System | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AutoDELFIA Immunoassay Screening System | EU IVDR | Eu Ivd Class A | On Market | 0 |
| AutoDELFIA Inhibin A kitย | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| AutoDELFIA Neonatal 17ฮฑ-OH-progesterone kitย | EU IVDD | Eu Ivd General | On Market | 0 |
| AutoDELFIA Neonatal IRT kit | EU IVDD | Eu Ivd General | On Market | 0 |
| AutoDELFIA Neonatal Thyroxine (T4) | EU IVDD | Eu Ivd General | On Market | 0 |
| AutoDELFIA Neonatal hTSH | EU IVDD | Eu Ivd General | On Market | 0 |
| AutoDELFIA PAPP-A | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| AutoDELFIA hAFP | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| AutoDELFIA hAFP/Free hCGร Dual | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| AutoDELFIA hCG | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| AutoDELFIA hLH Spec kit | EU IVDD | Eu Ivd General | On Market | 0 |
| AutoDELFIA hTSH Ultra | EU IVDD | Eu Ivd General | On Market | 0 |
| BoBsoft | EU IVDD | Eu Ivd General | On Market | 0 |
| BoBsoft | EU IVDD | Eu Ivd General | On Market | 0 |
| CHS MSMS Steroids Tool Box | EU IVDD | Eu Ivd General | Off Market | 0 |
| CHS MSMS Steroids kit | EU IVDD | Eu Ivd General | Off Market | 0 |
| DELFIA Diluent 3 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Diluent 3 | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Diluent II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Diluent II | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Enhancement Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Enhancement Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Enhancement Solution | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Free hCGร | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Inducer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Inducer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Neonatal 17ฮฑ-OH-progesterone | EU IVDD | Eu Ivd General | On Market | 0 |
| DELFIA Neonatal 17ฮฑ-OH-progesterone | EU IVDD | Eu Ivd General | On Market | 0 |
| DELFIA Neonatal IRT kit | EU IVDD | Eu Ivd General | On Market | 0 |
| DELFIA Neonatal IRT kitย | EU IVDD | Eu Ivd General | On Market | 0 |
| DELFIA Neonatal Thyroxine (T4) | EU IVDD | Eu Ivd General | On Market | 0 |
| DELFIA Neonatal hTSH | EU IVDD | Eu Ivd General | On Market | 0 |
| DELFIA Neonatal hTSH Ultra kit | EU IVDD | Eu Ivd General | On Market | 0 |
| DELFIA PAPP-A | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Wash Concentrate | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Wash Concentrate | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Wash Concentrate | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Wash Concentrate | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Xpress | EU IVDR | Eu Ivd Class A | On Market | 0 |
| DELFIA Xpress Free hCGร | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Xpress Free hCGร | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Xpress PAPP-A | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Xpress PAPP-A | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Xpress PAPP-A | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Xpress PAPP-A | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Xpress PAPP-A | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Xpress PlGF | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| DELFIA Xpress PlGF | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |