EU Manufacturer
๐บ๐ธ United States
Active
Genomic Health Inc.
SRN: US-MF-000018730
ยท
Penobscot Drive 301 , 94063 Redwood City, United States
Basic UDI-DIs
2
Total Devices
5
On Market
5
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
31
Basic Information
- Address
- Penobscot Drive 301 , 94063 Redwood City, United States
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdr
2
Classification
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Eu Ivd Class A
1
Eu Ivd Class C
1
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 31 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
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 | ||||
|---|---|---|---|---|
| Oncotype DX Breast Recurrence Scoreยฎ Computational Software | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Oncotype DX Breast Recurrence Scoreยฎ Kit | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Oncotype DX Breast Recurrence Scoreยฎ Kit | EU IVDR | Eu Ivd Class C | On Market | 0 |
| Oncotypeยฎ Sample Prep Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Oncotypeยฎ Sample Prep Kit | EU IVDR | Eu Ivd Class A | On Market | 0 |