EU Manufacturer
🇧🇷 Brazil
Active
SYSTHEX - SISTEMAS DE IMPLANTES OSSEO INTEGRADO LTDA
SRN: BR-MF-000043219
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PROCÓPIO FERREIRA MARTINS 586, 82940190 CURITIBA, Brazil
Basic UDI-DIs
313
Total Devices
313
On Market
313
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- PROCÓPIO FERREIRA MARTINS 586, 82940190 CURITIBA, Brazil
- [email protected]
- Phone
- +55 0800 600-6905
- Website
- www.systhex.com.br
Regulatory Overview
Regulation
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Eu Mdd
313
Classification
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Eu Md Class 2b
207
Eu Md Class 2a
106
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Expired / Withdrawn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) | 636429 | BSI Group The Netherlands B.V. | Aug 10, 2021 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇵🇹 Portugal
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| COUNTERSINK DRILL 4.1 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| COUNTERSINK DRILL 3.3 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| COUNTERSINK DRILL 3.3/4.1 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| COUNTERSINK DRILL 4.1 GUIDE | EU MDD | Eu Md Class 2a | On Market | 1 |
| COUNTERSINK DRILL 5.0 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drill Extension | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drill for Conical Implant 4.0 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drill for Conical Implant 5.0 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drill for Contra-Angle 1.1 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drill for Contra-Angle 1.3 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drill for Contra-Angle 1.6 MM | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drill for Fixation Pin 1,3mm Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Drill for Fixation Pin GUIDE | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 2,0mm with Stop | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 2,8mm with Stop | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,0mm with Stop | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,0x10mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,0x11,5mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,0x13mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,0x15mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,0x8,5mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,15mm with Stop | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,15x10mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,15x11,5mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,15x13mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,15x15mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,15x8,5mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3mm with Stop | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x10mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x10mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x11,5mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x11,5mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x13mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x13mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x15mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x15mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x8,5mm Sleeve 4,3 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,3x8,5mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,8mm with Stop | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,8x10mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,8x11,5mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,8x13mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,8x15mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 3,8x8,5mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 4,3mm with Stop | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 4,3x10mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 4,3x11,5mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 4,3x13mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 4,3x15mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| Helical Drill 4,3x8,5mm Sleeve 5,0 Guide | EU MDD | Eu Md Class 2a | On Market | 1 |