EU Manufacturer
๐บ๐ธ United States
Active
Nova Eye, Inc.
SRN: US-MF-000011341
ยท
Christy Street 41316, 94538 Fremont, United States
Basic UDI-DIs
4
Total Devices
12
On Market
12
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
18
Basic Information
- Address
- Christy Street 41316, 94538 Fremont, United States
- [email protected]
- Phone
- +1 800 391 23 16
- Website
- http://www.nova-eye.com
Regulatory Overview
Regulation
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Eu Mdd
2
Eu Mdr
2
Classification
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Eu Md Class 1
2
Eu Md Class 2a
2
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Expired / Withdrawn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 | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 41315215 | INTERTEK SEMKO AB | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 18 countries across Europe.
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iLumin | EU MDR | Eu Md Class 1 | On Market | 0 |
| iTrack 250A | EU MDD | Eu Md Class 2a | On Market | 1 |
| iTrack Advance | EU MDD | Eu Md Class 2a | On Market | 1 |