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Cardiohealth
EUDAMEDClass IIa (EU MDR)
Ref CARDIOHEALTH - GW2101Model CARDIOHEALTH - GW2101 - Guide wire
Identity
- Trade Name
- CARDIOHEALTH EUDAMED
- Device Name
- Guide wire EUDAMED
- Model / Reference
- CARDIOHEALTH - GW2101 - Guide wire EUDAMEDCARDIOHEALTH - GW2101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 86989077435376 EUDAMED
- Basic UDI-DI
- B-86989077435376 EUDAMED
- EMDN Code
- C04020299 PERIPHERAL VASCULAR GUIDEWIRES, THERAPEUTICAL - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Cardiohealth by Ares Medikal Sanayi Ticaret Ltd. Şti. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-86989077435376 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ares Medikal Sanayi Ticaret Ltd. Şti.
- EUDAMED SRN
- TR-MF-000029015
Sources (1)
- EUDAMED ccad9724-bc27-4e37-876f-d173cbd456ef 61 fields · synced Oct 6, 2026