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ASAHI Gaia PV
EUDAMEDClass IIa (EU MDR)
Ref PHW18R302S Ref PHW18R302PRef PHW18R302S
Identity
- Trade Name
- ASAHI Gaia PV EUDAMEDASAHI Peripheral Guide Wire ASAHI Gaia PV EUDAMED
- Device Name
- Peripheral 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 EUDAMEDASAHI Peripheral Guide Wire EUDAMED
- Model / Reference
- PHW18R302S EUDAMEDPHW18R302P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327106603 EUDAMED04547327106610 EUDAMED
- Basic UDI-DI
- 4547327DGW010NY EUDAMEDB-04547327106610 EUDAMEDB-04547327106603 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
Yes
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 Gaia PV by Asahi Intecc Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4547327DGW010NY | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4547327DGW010NY | 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 (3)
- EUDAMED cec4260c-0802-4932-a6bf-8f25ca19851f 61 fields · synced Aug 3, 2026
- EUDAMED 8b4da68b-0434-4b24-bb13-7c8b7649a68c 61 fields · synced May 18, 2026
- EUDAMED d6b66d14-dc50-4646-acd9-9d2bbb492d66 61 fields · synced Jul 31, 2026