EU Manufacturer
๐ฉ๐ช Germany
Active
EnvisionTEC GmbH
SRN: DE-MF-000009311
ยท
Brรผsseler Strasse 51, 45968 Gladbeck, Germany
Basic UDI-DIs
9
Total Devices
37
On Market
36
Off Market
1
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Brรผsseler Strasse 51, 45968 Gladbeck, Germany
- [email protected]
- Phone
- +49 2043 9875 0
- Website
- www.envisiontec.de
Regulatory Overview
Regulation
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Eu Mdr
8
Eu Mdd
1
Classification
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Eu Md Class 1
7
Eu Md Class 2a
2
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Expired / Withdrawn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) | 170739529 | DQS Medizinprodukte GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 32 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
๐ฑ๐ฎ Liechtenstein
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 | ||||
|---|---|---|---|---|
| E-Guard | EU MDD | Eu Md Class 2a | Off Market | 1 |
| E-Guard | EU MDR | Eu Md Class 1 | On Market | 0 |
| E-Guide | EU MDR | Eu Md Class 1 | On Market | 0 |
| E-Tray | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Dark Meharry | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Dark Pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Light Pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Medium Pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Original Pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Ultra+ Dark Meharry | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Ultra+ Dark Pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Ultra+ Light Pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Ultra+ Medium Pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Base Ultra+ Pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Smile A1 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Smile A2 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Smile A3 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Smile A3.5 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Smile B1 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Smile Bleach | EU MDR | Eu Md Class 1 | On Market | 0 |
| Flexcera Smile Ultra+ A1 0.5kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A1 1kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A1 1kg for Carbon | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A2 0.5kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A2 1kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A2 1kg for Carbon | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A3 0.5kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A3 1kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A3.5 0.5kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ A3.5 1kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ B1 0.5kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ B1 1kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ B1 1kg for Carbon | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ Bleach 0.5kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ Bleach 1kg | EU MDR | Eu Md Class 2a | On Market | 0 |
| Flexcera Smile Ultra+ Bleach 1kg for Carbon | EU MDR | Eu Md Class 2a | On Market | 0 |
| SmileGuard | EU MDR | Eu Md Class 1 | On Market | 0 |