EU Manufacturer
๐บ๐ธ United States
Active
Pivotal Health Solutions
SRN: US-MF-000042753
ยท
9th Avenue SW 3003, 57201 Watertown, United States
Basic UDI-DIs
6
Total Devices
30
On Market
30
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
16
Basic Information
- Address
- 9th Avenue SW 3003, 57201 Watertown, United States
- [email protected]
Regulatory Overview
Regulation
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Eu Mdr
4
Eu Mdd
2
Classification
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Eu Md Class 1
4
Eu Md Class 2a
2
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Expired / Withdrawn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 V | ECM19MDD004 | ENTE CERTIFICAZIONE MACCHINE SRL | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 16 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐พ Cyprus
๐ฉ๐ช Germany
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ท๐ด Romania
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Bariatric TheraP Electric Treatment Table | EU MDR | Eu Md Class 1 | On Market | 0 |
| Decompression Table | EU MDD | Eu Md Class 2a | On Market | 1 |
| EB8000 | EU MDR | Eu Md Class 1 | On Market | 0 |
| EB8000 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Epidural Positioning Device (EPD Package 2) | EU MDR | Eu Md Class 1 | On Market | 0 |
| ErgoBench | EU MDR | Eu Md Class 1 | On Market | 0 |
| ErgoBench | EU MDR | Eu Md Class 1 | On Market | 0 |
| ErgoBench | EU MDR | Eu Md Class 1 | On Market | 0 |
| ErgoBench | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergobasic | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergobasic | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergobasic | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergobasic | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle ES2000 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle ES2000 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle FX | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle FX | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle FX | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle Hylo | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle Hylo | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle Hylo | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergostyle Hylo | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ergowave | EU MDR | Eu Md Class 1 | On Market | 0 |
| Essential Thera-P Electric Treatment Table | EU MDR | Eu Md Class 1 | On Market | 0 |
| Essential Thera-P Electric Treatment Table | EU MDR | Eu Md Class 1 | On Market | 0 |
| Leg and Shoulder Table (LAST) | EU MDR | Eu Md Class 1 | On Market | 0 |
| TOWER DOC Decompression Table | EU MDD | Eu Md Class 2a | On Market | 1 |
| TheraP Electric Treatment Table | EU MDR | Eu Md Class 1 | On Market | 0 |
| TheraP Electric Treatment Table | EU MDR | Eu Md Class 1 | On Market | 0 |
| Traction Table | EU MDR | Eu Md Class 1 | On Market | 0 |