Identity
- Trade Name
- Gladius EUDAMEDASAHI Peripheral Guide Wire ASAHI Gladius 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
- PPW18R100S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327106382 EUDAMED
- Basic UDI-DI
- 4547327DGW010NY EUDAMEDB-04547327106382 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
Gladius 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 (2)
- EUDAMED a013684e-fb0f-4721-ae35-3a75e4ecfa4d 61 fields · synced Jul 11, 2026
- EUDAMED c0c0ecc7-3b3d-4702-95af-2590bc284b78 61 fields · synced May 18, 2026