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ASAHI Peripheral Guide Wire ASAHI Gaia PV
EUDAMEDClass IIa (EU MDR)
Ref PHW18R102SRef PHW18R102S
Identity
- Trade Name
- ASAHI Peripheral Guide Wire ASAHI Gaia PV EUDAMEDASAHI Gaia PV EUDAMED
- Device Name
- ASAHI Peripheral Guide Wire EUDAMEDPeripheral Guide Wire Astato 30, Astato XS 20, Astato XS 40, Halberd, ASAHI Gaia PV, Gladius, Gladius MG14 PV, Gladius MG14 PV ES, Gladius MG18 PV ES EUDAMED
- Model / Reference
- PHW18R102S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327106566 EUDAMED
- Basic UDI-DI
- B-04547327106566 EUDAMED4547327DGW010NY EUDAMED
- EMDN Code
- C04020201 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa 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 Peripheral Guide Wire ASAHI Gaia PV by Asahi Intecc Co., Ltd. — Class IIa — 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-04547327106566 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04547327106566 | Class IIa | 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 c0ee6a7a-b655-41b4-a761-92aa593c8486 61 fields · synced Jul 28, 2026
- EUDAMED a2e3683a-7ce0-4946-9bb1-2494142f0bfb 61 fields · synced May 17, 2026