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ASAHI Peripheral Guide Wire ASAHI Gladius
EUDAMEDClass IIa (EU MDR)
Ref PPW14R300P
Identity
- Trade Name
- ASAHI Peripheral Guide Wire ASAHI Gladius EUDAMED
- Device Name
- ASAHI Peripheral Guide Wire EUDAMED
- Model / Reference
- PPW14R300P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327106375 EUDAMED
- Basic UDI-DI
- B-04547327106375 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
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
ASAHI Peripheral Guide Wire ASAHI Gladius by Asahi Intecc Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04547327106375 | 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 (1)
- EUDAMED cf2710b0-fd47-4817-a3a7-7c928094a0eb 61 fields · synced May 23, 2026