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ASAHI PTCA GUIDE WIRE ASAHI MIRACLEbros 12 180cm
EUDAMEDFDA UDIClass III (EU MDR)
Ref AG14M070Ref AG14M270
Identity
- Trade Name
- ASAHI PTCA GUIDE WIRE ASAHI MIRACLEbros 12 180cm EUDAMEDMIRACLEBROS 12 EUDAMEDFDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide Wire EUDAMEDGrand Slam PCI Guide Wire, ASAHI Miracle 3 PCI Guide Wire, MIRACLEbros 3 PCI Guide Wire, ASAHI Miracle 6 PCI Guide Wire, MIRACLEbros 6 PCI Guide Wire, ASAHI Miracle 12 PCI Guide Wire, MIRACLEbros 12 PCI Guide Wire EUDAMED
- Model / Reference
- AG14M070 EUDAMEDFDA UDIAG14M270 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327058131 EUDAMEDFDA UDI04547327141130 EUDAMED
- Basic UDI-DI
- B-04547327058131 EUDAMED4547327BGW007NH EUDAMED
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, HYDROPHILIC EUDAMEDC04010202 CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.014 Inch FDA UDILength — 180 Centimeter FDA UDI
ASAHI PTCA GUIDE WIRE ASAHI MIRACLEbros 12 180cm by Asahi Intecc Co., Ltd. — Class III — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04547327058131 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327058131 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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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 e17dccd6-5772-4e24-89ab-08cb463f5f0e 61 fields · synced Sep 17, 2026
- FDA UDI 8129c76b-3a5b-429b-af41-6ae006ab572c 33 fields · synced May 30, 2026
- EUDAMED 83828fbe-b089-4d65-9613-98f0468be5c8 61 fields · synced Jul 8, 2026