Eu Mdd
Eu Md Class 2a
On The Market
๐ณ๐ฑ Netherlands
SteerEase
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1
Basic Information
- Primary DI
- 08720214000109
- Basic UDI-DI Code
- B-08720214000109
- Reference
- LE-SFA7F
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- LifeTech Scientific (Europe) B.V.
Additional Description
The SteerEaseTM Introducer consists of a sheath , a dilator, a loader, a hemostatic valve and a delivery cable. There are two types of sheaths with distal curve of 45ยฐ (SFA) and 180ยฐ (SFP). The SteerEaseTM Introducer is intended to reach the cardiovascular system or the peripheral vasculature and would provide a pathway to perform the delivery of the devices.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P0780 | VASCULAR AND CARDIAC PROSTHESES - ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2166785CE03 | DEKRA Certification B.V. |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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