Eu Mdd
Eu Md Class 3
On The Market
๐ณ๐ฑ Netherlands
CeraFlex
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1
Basic Information
- Primary DI
- 08720214005593
- Basic UDI-DI Code
- B-08720214005593
- Reference
- LE-PFOf-2518
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- LifeTech Scientific (Europe) B.V.
Additional Description
The CeraFlex PFO Closure System includes CeraFlex PFO Occluder and SteerEaseTMIntroducer. The PFO Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of patent foramen ovale (PFO). The PFO Occluder is self-expandable double discs device, which is made of a nitinol wire mesh that is shaped into two flat discs and a waist between the two discs. PET membranes sewn into each disc helpto seal the hole and provide a foundation for growth of tissue over the occluder after placement. All metallic structures are plated with titanium nitride (TiN) to improve the biocompatibility.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P07040303 | CARDIAC OCCLUDERS, FORAMEN OVALE AND BOTALLO DUCT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 2166785CE03&2166785DE08 | 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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