EU Manufacturer
๐บ๐ธ United States
Active
Invivo Corporation
SRN: US-MF-000002284
ยท
SW 47th Ave 3545, 32608 Gainesville, United States
Basic UDI-DIs
10
Total Devices
21
On Market
21
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- SW 47th Ave 3545, 32608 Gainesville, United States
- [email protected]
- Phone
- n/a
- Website
- n/a
Regulatory Overview
Regulation
Loading...
Eu Mdd
7
Eu Mdr
3
Classification
Loading...
Eu Md Class 2a
6
Eu Md Class 1
4
Device Types
Loading...
Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 059518 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G10595180026 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex V | G2S0595180025 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 059518 0026 | TรV SรD Product Service 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 | ||||
|---|---|---|---|---|
| ClarifEye Marker | EU MDR | Eu Md Class 1 | On Market | 0 |
| ClarifEye Needle | EU MDR | Eu Md Class 2a | On Market | 0 |
| DynaCAD | EU MDD | Eu Md Class 2a | On Market | 1 |
| Fiducial Marker Grid Block Assembly | EU MDR | Eu Md Class 1 | On Market | 0 |
| Fiducial Marker Sleeve Assembly | EU MDR | Eu Md Class 1 | On Market | 0 |
| Fully Automatic Biopsy Gun | EU MDD | Eu Md Class 2a | On Market | 1 |
| Fully Automatic Biopsy Gun | EU MDD | Eu Md Class 2a | On Market | 1 |
| Fully Automatic Biopsy Gun | EU MDD | Eu Md Class 2a | On Market | 1 |
| Lateral Grid dS Breast 16CH I/T | EU MDR | Eu Md Class 1 | On Market | 0 |
| MRI Needle Block 12G | EU MDR | Eu Md Class 1 | On Market | 0 |
| MRI Needle Block 14G | EU MDR | Eu Md Class 1 | On Market | 0 |
| MRI Needle Block 16G | EU MDR | Eu Md Class 1 | On Market | 0 |
| MRI Needle Block 18G | EU MDR | Eu Md Class 1 | On Market | 0 |
| MRI Needle Sleeve 12G | EU MDR | Eu Md Class 1 | On Market | 0 |
| MRI Needle Sleeve 14G | EU MDR | Eu Md Class 1 | On Market | 0 |
| MRI Needle Sleeve 16G | EU MDR | Eu Md Class 1 | On Market | 0 |
| MRI Needle Sleeve 18G | EU MDR | Eu Md Class 1 | On Market | 0 |
| Prostate Needle Guide | EU MDD | Eu Md Class 1 | On Market | 1 |
| Prostate Needle Guide | EU MDD | Eu Md Class 1 | On Market | 1 |
| Sentinelle, Biopsy Grid | EU MDR | Eu Md Class 1 | On Market | 0 |
| UroNav | EU MDD | Eu Md Class 2a | On Market | 1 |