Identity
- Trade Name
- Gladius MG18 PV ES EUDAMEDASAHI Peripheral Guide Wire ASAHI Gladius MG18 PV ES 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
- PP18R304S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327124829 EUDAMED
- Basic UDI-DI
- 4547327DGW010NY EUDAMEDB-04547327124829 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 MG18 PV ES 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Asahi Intecc Co., Ltd.
- EUDAMED SRN
- JP-MF-000010199
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f617413d-6ca0-4e66-b97e-5438fd826d40 61 fields · synced Jun 19, 2026
- EUDAMED a31b8648-59fa-44c2-a771-78c41a5d0849 61 fields · synced May 18, 2026