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ASAHI PTCA Guide Wire Rinato
EUDAMEDClass III (EU MDR)
Ref AGH146000Ref AGH146000J
Identity
- Trade Name
- ASAHI PTCA Guide Wire Rinato EUDAMEDASAHI PTCA Guide Wire Rinato J EUDAMEDRinato EUDAMED
- Device Name
- ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide Wire EUDAMEDPCI Guide Wire Rinato / PCI Guide Wire PROWATER, PCI Guide Wire Route / PCI Guide Wire PROWATERflex, PCI Guide Wire ULTIMATEbros 3 EUDAMED
- Model / Reference
- AGH146000 EUDAMEDAGH146000J EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327077248 EUDAMED04547327077354 EUDAMED
- Basic UDI-DI
- B-04547327077248 EUDAMEDB-04547327077354 EUDAMED4547327DGW004P5 EUDAMED
- EMDN Code
- C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMEDC04010201 CORONARY ARTERY THERAPEUTIC GUIDEWIRES, 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
EUDAMEDEUDAMED
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 Rinato by Asahi Intecc Co., Ltd. — Class III — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04547327077248 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327077248 | 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 7dff6404-997d-4ccb-9626-4ef68d4eada6 61 fields · synced Aug 2, 2026
- EUDAMED 4af2a7c3-7a8b-478f-90c2-f4b98550d97e 61 fields · synced May 18, 2026
- EUDAMED 515eaba1-93a2-48cd-8c8b-e79042076e91 61 fields · synced Jul 8, 2026