EU Manufacturer
๐บ๐ธ United States
Active
Nidek Medical Products Inc.
SRN: US-MF-000007253
ยท
Valley East Industrial Drive 3949, 35217 Birmingham, United States
Basic UDI-DIs
6
Total Devices
22
On Market
22
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
15
Basic Information
- Address
- Valley East Industrial Drive 3949, 35217 Birmingham, United States
- [email protected]
- Website
- www.nidekmedical.com
Regulatory Overview
Regulation
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Eu Mdd
5
Eu Mdr
1
Classification
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Eu Md Class 2a
5
Eu Md Class 2b
1
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 41312638-02 | INTERTEK SEMKO AB | Oct 22, 2023 | |||
| MDD Annex II (excluding section 4) | 41312638 | INTERTEK SEMKO AB | Oct 22, 2023 |
Market Presence
Devices from this manufacturer are available in 15 countries across Europe.
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฒ๐น Malta
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐น๐ท Tรผrkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Mark 5 Nuvo | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo 10 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo 10 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo 10 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo 8 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo 8 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo Lite | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo Lite | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo Lite | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo Lite | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo Lite | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo Lite | EU MDR | Eu Md Class 2b | On Market | 0 |
| Mark 5 Nuvo Lite | EU MDD | Eu Md Class 2a | On Market | 1 |
| Mark 5 Nuvo Lite | EU MDD | Eu Md Class 2a | On Market | 1 |
| Mark 5 Nuvo Lite | EU MDD | Eu Md Class 2a | On Market | 1 |
| Mark 5 Nuvo Lite | EU MDD | Eu Md Class 2a | On Market | 1 |
| Mark 5 Nuvo Lite 3 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Max 30 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Max 30 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Max 30 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Nuvo Nano | EU MDR | Eu Md Class 2b | On Market | 0 |
| Nuvo Nano | EU MDD | Eu Md Class 2a | On Market | 1 |