EU Manufacturer
🇩🇪 Germany
Active
Fiagon GmbH
SRN: DE-MF-000010763
·
Neuendorfstr. 23b, 16761 Hennigsdorf, Germany
Basic UDI-DIs
14
Total Devices
33
On Market
33
Off Market
0
Certificates
1
Valid
1
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Neuendorfstr. 23b, 16761 Hennigsdorf, Germany
- [email protected]
- Phone
- +49 3302 201 21 10
- Website
- www.fiagon.de
Regulatory Overview
Regulation
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Eu Mdr
14
Classification
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Eu Md Class 1
12
Eu Md Class 2a
2
Device Types
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Certificate Health
Total
1
Valid
1
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDR QMS | FI24/00000064 | SGS FIMKO OY | MDR | Oct 2024 | Oct 27, 2029 | Issued |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 4K Navigation Unit Cube4D | EU MDR | Eu Md Class 2a | On Market | 0 |
| Adapter for Clipsensor | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adapter for Clipsensor stenosis | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adapter for Flexsensor | EU MDR | Eu Md Class 1 | On Market | 0 |
| Adhesive Pad | EU MDR | Eu Md Class 1 | On Market | 0 |
| FlexArm Adapter for siderail | EU MDR | Eu Md Class 1 | On Market | 0 |
| FlexPointer | EU MDR | Eu Md Class 2a | On Market | 0 |
| FlexPointer 1.5mm | EU MDR | Eu Md Class 2a | On Market | 0 |
| FlexTube 3mm | EU MDR | Eu Md Class 2a | On Market | 0 |
| FlexTube 4mm | EU MDR | Eu Md Class 2a | On Market | 0 |
| Localizer Adhesive Pad | EU MDR | Eu Md Class 1 | On Market | 0 |
| Localizer Adhesive Pad C-Type | EU MDR | Eu Md Class 2a | On Market | 0 |
| Localizer Bone Anchor C-Type | EU MDR | Eu Md Class 2a | On Market | 0 |
| Localizer K-Wire | EU MDR | Eu Md Class 2a | On Market | 0 |
| MapperBridge | EU MDR | Eu Md Class 1 | On Market | 0 |
| MultiPad | EU MDR | Eu Md Class 1 | On Market | 0 |
| Navigation Headrest Horseshoe | EU MDR | Eu Md Class 1 | On Market | 0 |
| Navigation Headrest Universal | EU MDR | Eu Md Class 1 | On Market | 0 |
| Navigation Sensor | EU MDR | Eu Md Class 2a | On Market | 0 |
| Navigation Sensor FlexArm | EU MDR | Eu Md Class 2a | On Market | 0 |
| Navigation Unit Cube4D | EU MDR | Eu Md Class 2a | On Market | 0 |
| PointerShell 3mm | EU MDR | Eu Md Class 1 | On Market | 0 |
| PointerShell 4mm | EU MDR | Eu Md Class 1 | On Market | 0 |
| PointerShell 5mm | EU MDR | Eu Md Class 1 | On Market | 0 |
| PointerShell Universal | EU MDR | Eu Md Class 1 | On Market | 0 |
| PointerTube Keat | EU MDR | Eu Md Class 2a | On Market | 0 |
| PointerTube Kennedy | EU MDR | Eu Md Class 2a | On Market | 0 |
| RIWOtrack Clipsensor | EU MDR | Eu Md Class 1 | On Market | 0 |
| RIWOtrack Clipsensor stenosis | EU MDR | Eu Md Class 1 | On Market | 0 |
| RIWOtrack Flexsensor | EU MDR | Eu Md Class 2a | On Market | 0 |
| RIWOtrack Navigation Unit Cube4D | EU MDR | Eu Md Class 2a | On Market | 0 |
| RegistrationPointer | EU MDR | Eu Md Class 1 | On Market | 0 |
| VirtuEye | EU MDR | Eu Md Class 1 | On Market | 0 |