Eu Mdd
Eu Md Class 3
On The Market
🇰🇷 South Korea
Nexsphere™
Devices (same UDI-DI)
1
Certificates
1
Countries
10
Notified Bodies
1
Basic Information
- Primary DI
- 08800038404526
- Basic UDI-DI Code
- B-08800038404526
- Reference
- UIGB500
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- NEXTBIOMEDICAL CO., LTD.
Additional Description
Nexsphere™ is a powder-shaped embolic agent for endovascular embolization. It is composed of hydrophilic material and used to proceed arterial embolization with contrast agent. Swollen microspheres are injected into the blood vessel through the catheter to temporarily block the bleeding of the blood vessels or block the blood supply to the tissues.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C010402020303 | EMBOLISATION PARTICLES AND MICROSPHERES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2020-MDD/QS-037/A | 3EC International a.s. | Expired |
Available In Countries
🇩🇪 Germany
🇩🇰 Denmark
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇮🇸 Iceland
🇮🇹 Italy
🇳🇱 Netherlands
🇳🇴 Norway
🇸🇪 Sweden
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