EU Manufacturer
๐บ๐ธ United States
Active
Elixir Medical Corporation
SRN: US-MF-000013041
ยท
N. McCarthy Blvd 920, 95035 Milpitas, United States
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
3
Valid
1
Expiring < 6mo
0
Countries
3
Watch Elixir Medical Corporation for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- N. McCarthy Blvd 920, 95035 Milpitas, United States
- [email protected]
- Phone
- + 1 408 636 2000
- Website
- https://elixirmedical.com/
Regulatory Overview
Regulation
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Eu Mdd
2
Classification
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Eu Md Class 3
2
Device Types
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Certificate Health
Total
3
Valid
1
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | 2020-MDD/QS-086/A | 3EC International a.s. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2020-MDD/DE-087/A | 3EC International a.s. | May 26, 2024 | |||
| MDR QMS | 2024-MDR/QS-061 | 3EC International a.s. | MDR | Nov 2024 | Nov 08, 2029 | Issued |
Market Presence
Devices from this manufacturer are available in 3 countries across Europe.
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ธ๐ช Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| DynamX Sirolimus Eluting Coronary Bioadaptor System | EU MDD | Eu Md Class 3 | On Market | 1 |
| DynamX Sirolimus Eluting Coronary Bioadaptor System | EU MDD | Eu Md Class 3 | On Market | 2 |