EU Manufacturer
🇨🇦 Canada
Active
Prollenium Medical Technologies Inc.
SRN: CA-MF-000017924
·
Industrial Pkwy. N. 138, L4G 4C3 Aurora, Canada
Basic UDI-DIs
32
Total Devices
32
On Market
32
Off Market
0
Certificates
16
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Industrial Pkwy. N. 138, L4G 4C3 Aurora, Canada
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
32
Classification
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Eu Md Class 3
32
Device Types
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Certificate Health
Total
16
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
16
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 301001848ADDE16 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 301001848ADDE15 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 301001848ADDE14 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 301001848ADDE13 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 301001848ADDE12 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 301001848ADDE11 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 301001848ADDE9 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II (excluding section 4) | 301001848ADDE10 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II Section 4 | 301001848DE7 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II Section 4 | 301001848ADDE8 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II Section 4 | 301001848DE6 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II Section 4 | 301001848DE5 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II Section 4 | 301001848DE4 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II Section 4 | 301001848DE3 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II Section 4 | 301001848DE2 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 | |||
| MDD Annex II Section 4 | 301001848DE1 | NATIONAL EVALUATION CENTER OF QUALITY AND TECHNOLOGY IN HEALTH S.A.- EKAPTY | May 24, 2024 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Revanesse® Outline™ + with Lidocaine 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| RESORBABLE FILLING AND RECONSTRUCTION DEVICES | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® + with Lidocaine 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® + with Lidocaine 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Contour 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Contour 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Contour™ + with Lidocaine 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Contour™ + with Lidocaine 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Kiss 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Kiss 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Kiss™ + with Lidocaine 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Kiss™ + with Lidocaine 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Outline 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Outline 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Outline™ + with Lidocaine 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Pure 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Pure 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Pure™ + with Lidocaine 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Pure™ + with Lidocaine 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Revise 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Revise™ + with Lidocaine 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Revise™ + with Lidocaine 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Shape 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Shape 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Shape™ + with Lidocaine 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Shape™ + with Lidocaine 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Ultra 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Ultra 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Ultra™ + with Lidocaine 1.0 mL | EU MDD | Eu Md Class 3 | On Market | 1 |
| Revanesse® Ultra™ + with Lidocaine 1.2 mL | EU MDD | Eu Md Class 3 | On Market | 1 |