EU Manufacturer
🇺🇸 United States
Active
USGI Medical
SRN: US-MF-000031970
·
Calle Cordillera 1140, 92673 San Clemente, United States
Basic UDI-DIs
6
Total Devices
6
On Market
6
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
8
Basic Information
- Address
- Calle Cordillera 1140, 92673 San Clemente, United States
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
6
Classification
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Eu Md Class 1
4
Eu Md Class 2a
1
Eu Md Class 2b
1
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Expired / Withdrawn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) | 600283 | BSI Group The Netherlands B.V. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 8 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇩🇪 Germany
🇪🇸 Spain
🇮🇹 Italy
🇱🇺 Luxembourg
🇳🇱 Netherlands
🇵🇹 Portugal
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Transport Retroflex | EU MDD | Eu Md Class 1 | On Market | 1 |
| Transport-R | EU MDD | Eu Md Class 1 | On Market | 1 |
| g-Cath™ EZ delivery catheter with Snowshoe® suture anchors | EU MDD | Eu Md Class 2b | On Market | 1 |
| g-Lix Tissue Grasper | EU MDD | Eu Md Class 2a | On Market | 1 |
| g-Prox EZ-16 | EU MDD | Eu Md Class 1 | On Market | 1 |
| g-Prox EZ-33 | EU MDD | Eu Md Class 1 | On Market | 1 |