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ASAHI PTCA Guide Wire PROWATERflex 300cm
EUDAMEDFDA UDIClass III (EU MDR)
Ref AGH147300Ref AGH147000
Identity
- Trade Name
- ASAHI PTCA Guide Wire PROWATERflex 300cm EUDAMEDASAHI PTCA Guide Wire PROWATERflex EUDAMEDASAHI PTCA GUIDE WIRE PROWATERflex 300cm EUDAMEDPROWATERflex FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- ASAHI PTCA GUIDE WIRE, ASAHI PTCA Guide Wire EUDAMED
- Model / Reference
- AGH147300 EUDAMEDFDA UDIAGH147000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327077491 EUDAMED04547327077484 EUDAMED04547327056328 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04547327077491 EUDAMEDB-04547327077484 EUDAMEDB-04547327056328 EUDAMED
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04030201 INTERVENTIONAL CORONARY AND PERIPHERAL VASCULAR GUIDE WIRES, 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
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
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 — 300 Centimeter FDA UDI
ASAHI PTCA Guide Wire PROWATERflex 300cm by Asahi Intecc Co., Ltd. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04547327077491 | 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 (4)
- EUDAMED 8d98dddb-55b9-4d9c-8917-e0a8144dfe58 61 fields · synced Jul 23, 2026
- EUDAMED 855ab4b4-f641-4ec5-add4-62f0ad6cd490 61 fields · synced May 18, 2026
- EUDAMED c80d89d9-4198-47f9-8a2f-620f546e827c 61 fields · synced May 19, 2026
- FDA UDI 81b19b92-f3e3-4336-8bda-6f7c17afae15 33 fields · synced May 30, 2026