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ASAHI PTCA Guide Wire CONFIANZA PRO 12 300cm
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref AGH143391Ref AGH143091
Identity
- Trade Name
- ASAHI PTCA Guide Wire CONFIANZA PRO 12 300cm EUDAMEDASAHI PTCA Guide Wire CONFIANZA PRO 12 EUDAMED
- Device Name
- ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide Wire EUDAMED
- Model / Reference
- AGH143391 EUDAMEDAGH143091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327085533 EUDAMED04547327085441 EUDAMED
- Basic UDI-DI
- B-04547327085533 EUDAMEDB-04547327085441 EUDAMED
- EMDN Code
- C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Austria 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
ASAHI PTCA Guide Wire CONFIANZA PRO 12 300cm by Asahi Intecc Co., Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041531 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327085533 | Class III | Active |
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Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
- EUDAMED SRN
- JP-MF-000010199
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 82c4edf7-5cd0-49f0-a54c-cb02ca0e1c8c 61 fields · synced Jul 23, 2026
- EUDAMED 8512de67-1fe4-4c4d-ab53-6eddda3242fe 61 fields · synced May 17, 2026
- FDA 510(k) K041531 1 fields · synced May 18, 2026