Devices (same UDI-DI)
1
Certificates
2
Countries
2
Notified Bodies
2
Basic Information
- Primary DI
- 18904224906676
- Basic UDI-DI Code
- B-18904224906676
- Reference
- EVF20013
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
Additional Description
Everolimus Eluting Coronary Stent System comprises of following components -A balloon-expandable L605 Cobalt Chromium Coronary Stent - A stent coating that consists of a blend of anti-proliferative drug and polymers 1. Immunosuppressant drug Everolimus 2. Bio-compatible, bio-degradable co-polymer coating which acts as drug reservoir and drug release platform -A rapid-exchange stent delivery PTCA balloon catheter -The stent is pre mounted on balloon catheter & placed between two platinum-iridium radio opaque markers bands.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P070402010301 | CORONARY DRUG ELUTING STENTS (DES) WITH POLYMERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1783-MDD-085 | TURKISH STANDARDS INSTITUTION (TSE) | Expired |
| MDD Annex II Section 4 | 1783-MDD-086 | TURKISH STANDARDS INSTITUTION (TSE) | Expired |
Available In Countries
🇩🇪 Germany
🇹🇷 Türkiye
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