Identity
- Trade Name
- Navajo EUDAMED
- Device Name
- Navajo PTA Balloon Dilatation Catheter EUDAMED
- Model / Reference
- 21310080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970226520542 EUDAMED
- Basic UDI-DI
- 697022652104FL EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Category: Peripheral angioplasty balloon catheter, basic
Navajo by Curatia Medical Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
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- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
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 | 697022652104FL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Curatia Medical Limited
- EUDAMED SRN
- CN-MF-000015976
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (1)
- EUDAMED 48e95f10-b895-4219-93da-3bd14fcb5f75 61 fields · synced Jun 18, 2026