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ASAHI NEO'S PTCA Guide Wire ASAHI Route 300cm
EUDAMEDClass III (EU MDR)
Ref AGH147300Ref AGH147000
Identity
- Trade Name
- ASAHI NEO'S PTCA Guide Wire ASAHI Route 300cm EUDAMEDASAHI NEO'S PTCA Guide Wire Route EUDAMED
- Device Name
- ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide Wire EUDAMED
- Model / Reference
- AGH147300 EUDAMEDAGH147000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327056908 EUDAMED04547327056618 EUDAMED
- Basic UDI-DI
- B-04547327056908 EUDAMEDB-04547327056618 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 NEO'S PTCA Guide Wire ASAHI Route 300cm by Asahi Intecc Co., Ltd. — Class III — 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-04547327056908 | 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 (2)
- EUDAMED 48920a58-24b1-4743-ab9e-8fd8f7d95eba 61 fields · synced Jul 27, 2026
- EUDAMED e93b1988-c76e-4e0c-9820-7a9ef9de7d77 61 fields · synced May 18, 2026