EU Manufacturer
๐บ๐ธ United States
Active
DxTx Medical, Inc.
SRN: US-MF-000026795
ยท
Alpha Dr 639, 15238 Pittsburgh, United States
Basic UDI-DIs
9
Total Devices
9
On Market
9
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
25
Basic Information
- Address
- Alpha Dr 639, 15238 Pittsburgh, United States
- [email protected]
- Phone
- 4124353867
- Website
- https://dxtxmedical.com/
Regulatory Overview
Regulation
Loading...
Eu Mdr
7
Eu Mdd
2
Classification
Loading...
Eu Md Class 1
7
Eu Md Class 2a
2
Device Types
Loading...
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 36594 | GMED SAS | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 25 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 1.5T Ingenia Endorectal Coil Interface Device (eCoilยฎ) | EU MDR | Eu Md Class 1 | On Market | 0 |
| 3.0T Ingenia Endorectal Coil Interface Device (eCoilยฎ) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Endorectal MRI Coil II for 3.0T MR Imaging of the Prostate (e2CoilTM) โ Siemens | EU MDR | Eu Md Class 1 | On Market | 0 |
| Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoilยฎ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoilยฎ) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Pro-Tx Endorectal Balloon | EU MDR | Eu Md Class 1 | On Market | 0 |
| Siemens 1.5T Endo Interface (eCoilยฎ) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Siemens 3.0T Endo Interface (eCoilยฎ) | EU MDR | Eu Md Class 1 | On Market | 0 |
| Siemens 3.0T Endo Interface II with Tim 4G Slide Connect (e2CoilTM) | EU MDR | Eu Md Class 1 | On Market | 0 |