Eu Mdd
Eu Md Class 2a
On The Market
๐ณ๐ฑ Netherlands
Jade PTA
Devices (same UDI-DI)
1
Certificates
1
Countries
23
Notified Bodies
1
Basic Information
- Primary DI
- 08717853299261
- Basic UDI-DI Code
- B-08717853299261
- Reference
- 560-015-41
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- OrbusNeich Medical, B.V.
Additional Description
The JADE Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter is a rapid exchange balloon catheter for peripheral indications, not for coronary or neuro-vasculature. Balloon Diameters range from 1.5 mm to 6.0 mm and catheter length is 150 cm. The balloon material is made of a minimally compliant material. The balloons of 1.5-4.0 mm have a rated burst pressure of 22 atm, 4.5-5.0 mm with a rated burst pressure of 20 atm and 5.5-6.0 mm with a rated burst pressure of 18 atm.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C010402020101 | PTA BALLOON DILATATION CATHETERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE 619995 | BSI Group The Netherlands B.V. | Expired |
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
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
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