EU Manufacturer
🇺🇸 United States
Active
Resoundant
SRN: US-MF-000037180
·
1st Ave. SW 421, 55902 Rochester, United States
Basic UDI-DIs
6
Total Devices
6
On Market
6
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
3
Basic Information
- Address
- 1st Ave. SW 421, 55902 Rochester, United States
- [email protected]
- Phone
- +1 507 322 0011
- Website
- https://www.resoundant.com/
Regulatory Overview
Regulation
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Eu Mdd
3
Eu Mdr
3
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Expired / Withdrawn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 II (excluding section 4) | 1434-MDD-451/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 3 countries across Europe.
🇩🇪 Germany
🇮🇹 Italy
🇳🇱 Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Hepatogram plus | EU MDD | Eu Md Class 2a | On Market | 1 |
| MR Elastography System | EU MDD | Eu Md Class 2a | On Market | 1 |
| MRE Phantom Kit | EU MDD | Eu Md Class 1 | On Market | 0 |
| Resoundant Flex Passive Driver, Large | EU MDR | Eu Md Class 1 | On Market | 0 |
| Resoundant Flex Passive Driver, Small | EU MDR | Eu Md Class 1 | On Market | 0 |
| Resoundant Passive Driver, Rigid | EU MDR | Eu Md Class 1 | On Market | 0 |