Devices (same UDI-DI)
1
Certificates
2
Countries
18
Notified Bodies
2
Basic Information
- Primary DI
- 18904224901329
- Basic UDI-DI Code
- B-18904224901329
- Reference
- BIM27522560
- 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
The Biomime™ Morph Sirolimus Eluting 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. Anti-proliferative drug Sirolimus (also known as Rapamycin) 2. Bio-compatible, bio-degradable co-polymer coating which acts as drug reservoir and drug release platform -A Tapered 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 Section 4 | 1434-MDD-333/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
| MDD Annex II (excluding section 4) | 1434-MDD-334/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇪🇪 Estonia
🇪🇸 Spain
🇫🇮 Finland
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇹 Italy
🇱🇹 Lithuania
🇳🇱 Netherlands
🇵🇱 Poland
🇵🇹 Portugal
🇸🇪 Sweden
🇸🇰 Slovakia
🇹🇷 Türkiye
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