Eu Mdd
Eu Md Class 3
On The Market
๐ณ๐ฑ Netherlands
Scoreflex NC
Devices (same UDI-DI)
1
Certificates
1
Countries
24
Notified Bodies
1
Basic Information
- Primary DI
- 08719244950157
- Basic UDI-DI Code
- B-08719244950157
- Reference
- 630-104-1
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- OrbusNeich Medical, B.V.
Additional Description
The Scoreflex NC Coronary Balloon Dilatation Catheter, a scoring balloon catheter, is designed for easy guidewire exchange. Balloon diameter is 1.75, 2.0, 2.25, 2.5, 2.75, 3.0, 3.5 and 4.0mm and the balloon length is 10, 15 and 20mm. The working length is 140cm. The balloon material is made of a minimally compliant material with a rated burst pressure of 20 atmospheres.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C010401020101 | PTCA BALLOON DILATION CATHETERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | CE 646780 | BSI Group The Netherlands B.V. | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
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