EU Manufacturer
๐บ๐ธ United States
Active
Uromedica, Incorporated
SRN: US-MF-000008932
ยท
Berkshire Lane N 1840, 55441 Plymouth, United States
Basic UDI-DIs
17
Total Devices
17
On Market
17
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
30
Basic Information
- Address
- Berkshire Lane N 1840, 55441 Plymouth, United States
- [email protected]
- Phone
- +1 763 694 9880
- Website
- www.uromedica-inc.com
Regulatory Overview
Regulation
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Eu Mdd
17
Classification
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Eu Md Class 2b
14
Eu Md Class 1
3
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | G1 045789 0018 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | Q5 045789 0019 | TรV SรD Product Service GmbH | Jun 27, 2025 |
Market Presence
Devices from this manufacturer are available in 30 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
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 12cm ProACT Double- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 12cm ProACT Single- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 14cm ProACT Double- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 14cm ProACT Single- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 5cm ACT Double- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 5cm ACT Single- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 6cm ACT Double- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 6cm ACT Single- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 7cm ACT Double- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 7cm ACT Single- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8cm ACT Double- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 8cm ACT Single- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 9cm ACT Double- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| 9cm ACT Single- INTL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Uromedica ACT/ProACT Blunt Trocar | EU MDD | Eu Md Class 1 | On Market | 1 |
| Uromedica ACT/ProACT Implantation Instrument Set | EU MDD | Eu Md Class 1 | On Market | 1 |
| Uromedica ACT/ProACT Tissue Expanding Device II | EU MDD | Eu Md Class 1 | On Market | 1 |