Devices (same UDI-DI)
1
Certificates
1
Countries
3
Notified Bodies
1
Basic Information
- Primary DI
- 18904224919720
- Basic UDI-DI Code
- B-18904224919720
- Reference
- PRB0500080B
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
Additional Description
The PromesaTM BMS – Self-Expanding Nitinol Peripheral Stent System is a GHTF Class D Implantation Medical Device. This device consists of following components – a) A self-expandable stent made from Nitinol alloy. b) An over-the-wire (OTW) stent delivery system consisting of PTA catheter that has flexible retractable sheath. The stent is pre-loaded on the delivery catheter constrained by covering it with the sheath. The stent is deployed by retracting the sheath which allows the stent to expand against the lesion in the arterial lumen to restore its patency.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P070402020102 | NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1783-MDD-111 | TURKISH STANDARDS INSTITUTION (TSE) | Expired |
Available In Countries
🇨🇿 Czechia
🇩🇪 Germany
🇪🇸 Spain
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