Eu Mdd
Eu Md Class 3
On The Market
🇺🇸 United States
iCLAS™ Cryoablation Catheter
Devices (same UDI-DI)
1
Certificates
2
Countries
5
Notified Bodies
2
Basic Information
- Primary DI
- D-109-0013-001S9
- Basic UDI-DI Code
- B-109-0013-001S9
- Reference
- 109-0013-001
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Adagio Medical, Inc.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C020302 | ARRHYTHMOGENIC FOCI CRYOENERGY ABLATION CATHETERS [correction as of 2025-01-01] |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 103403 0002 | TÜV SÜD Product Service GmbH | Expired |
| MDD Annex II Section 4 | G7 103403 0005 | TÜV SÜD Product Service GmbH | Expired |
Available In Countries
🇧🇪 Belgium
🇩🇪 Germany
🇮🇪 Ireland
🇳🇱 Netherlands
🇬🇧 United Kingdom
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