Identity
- Trade Name
- Armada™ 14 NC PTA Catheter EUDAMED
- Device Name
- Peripheral Dilatation Catheter, Armada 14 NC EUDAMED
- Model / Reference
- 2310375-010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717648356193 EUDAMED
- Basic UDI-DI
- 8717648PDC0006U5 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Armada™ 14 NC PTA Catheter by Abbott Medical — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8717648PDC0006U5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
- EUDAMED SRN
- US-MF-000003851
- Authorised Representative
- Abbott Vascular International BE-AR-000002043
Sources (1)
- EUDAMED f1cc1688-d5b9-49fb-a964-282478090729 61 fields · synced Jul 30, 2026