EU Manufacturer
๐บ๐ธ United States
Active
JenaValve Technology, Inc.
SRN: US-MF-000023455
ยท
Cromwell 4, 92618 Irvine, United States
Basic UDI-DIs
10
Total Devices
10
On Market
10
Off Market
0
Certificates
3
Valid
0
Expiring < 6mo
0
Countries
6
Basic Information
- Address
- Cromwell 4, 92618 Irvine, United States
- [email protected]
- Phone
- +1 949 767 2091
- Website
- www.jenavalve.com
Regulatory Overview
Regulation
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Eu Mdd
10
Classification
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Eu Md Class 3
10
Device Types
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Certificate Health
Total
3
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
3
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-327 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 | |||
| MDD Annex II Section 4 | 1343-MDD-328 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 | |||
| MDD Annex II Section 4 | 1434-MDD-328 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 6 countries across Europe.
๐ฆ๐น Austria
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ซ๐ท France
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Trilogy Delivery Catheter | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Delivery Catheter | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Delivery Catheter | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Heart Valve | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Heart Valve | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Heart Valve | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Loading Tools | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Loading Tools | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Loading Tools | EU MDD | Eu Md Class 3 | On Market | 2 |
| Trilogy Sheath/Dilator | EU MDD | Eu Md Class 3 | On Market | 2 |