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ASAHI Peripheral Guide Wire ASAHI Halberd
EUDAMEDClass IIa (EU MDR)
Ref PHW18R201SRef PHW18R201PRef PHW18R201S Ref PHW18R101PRef PHW18R101SRef PHW18R101S Ref PHW18R201P Ref PHW18R101P
Identity
- Trade Name
- ASAHI Peripheral Guide Wire ASAHI Halberd EUDAMEDHalberd 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
- PHW18R201S EUDAMEDPHW18R201P EUDAMEDPHW18R101P EUDAMEDPHW18R101S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327106528 EUDAMED04547327106535 EUDAMED04547327106511 EUDAMED04547327106504 EUDAMED
- Basic UDI-DI
- B-04547327106528 EUDAMEDB-04547327106535 EUDAMED4547327DGW010NY EUDAMEDB-04547327106511 EUDAMEDB-04547327106504 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 Halberd 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 | B-04547327106528 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-04547327106528 | 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 (8)
- EUDAMED fcfb8027-b657-41af-a644-05ce17e540b6 61 fields · synced Jul 31, 2026
- EUDAMED 83abfa98-38b2-4f32-a1ec-6588aa257599 61 fields · synced May 16, 2026
- EUDAMED a2f7d17e-bb14-4227-a139-005632a3b08f 61 fields · synced May 17, 2026
- EUDAMED beaa63ca-ba2d-4422-8700-558e8b09f604 61 fields · synced May 17, 2026
- EUDAMED 443f1616-fbf4-4eb4-bf8c-f53aaa677719 61 fields · synced May 18, 2026
- EUDAMED b560b61e-5ba7-46d4-b400-20f59d675a53 61 fields · synced Jul 9, 2026
- EUDAMED fe6dcaca-f51f-4534-b672-22fd8ad925a3 61 fields · synced Jul 29, 2026
- EUDAMED 59386204-9307-4eb8-aaf7-b4da7e332f4d 61 fields · synced Jul 30, 2026