Eu Mdd
Eu Md Class 3
On The Market
๐บ๐ธ United States
DynamX Sirolimus Eluting Coronary Bioadaptor System
Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 00817508013025
- Basic UDI-DI Code
- B-00817508013025
- Reference
- VIR3038
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Elixir Medical Corporation
Additional Description
Drug eluting coronary bioadaptor system intended to improve coronary luminal diameter in patients with symptomatic ischemic heart disease
CND Nomenclature Codes
| Code | Description |
|---|---|
| P070402010301 | CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 2020-MDD/QS-086/A | 3EC International a.s. | Expired |
Available In Countries
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ธ๐ช Sweden
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