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ASAHI PTCA Guide Wire MIRACLEbros 12
EUDAMEDClass III (EU MDR)
Ref AG14M070Ref AG14M370
Identity
- Trade Name
- ASAHI PTCA Guide Wire MIRACLEbros 12 EUDAMEDASAHI PTCA Guide Wire MIRACLEbros 12 300cm EUDAMED
- Device Name
- ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide Wire EUDAMED
- Model / Reference
- AG14M070 EUDAMEDAG14M370 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327085410 EUDAMED04547327085502 EUDAMED
- Basic UDI-DI
- B-04547327085410 EUDAMEDB-04547327085502 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 MIRACLEbros 12 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-04547327085410 | 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 fb6778b5-07a6-4e6a-9efc-11c890c636a5 61 fields · synced Jul 31, 2026
- EUDAMED 8acf1f4a-f403-47f5-b060-94bc3844b3a3 61 fields · synced May 18, 2026