← Back to catalogue
ASAHI Peripheral Guide Wire Regalia XS 1.0
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref PAGP140000
Identity
- Trade Name
- ASAHI Peripheral Guide Wire Regalia XS 1.0 EUDAMED
- Device Name
- ASAHI Peripheral Guide Wire EUDAMED
- Model / Reference
- PAGP140000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327076685 EUDAMED
- Basic UDI-DI
- B-04547327076685 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 Regalia XS 1.0 by Asahi Intecc Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K083146 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04547327076685 | 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 e0143fdc-7ea4-465c-ab5d-7a746515f3af 61 fields · synced Jul 8, 2026
- FDA 510(k) K083146 1 fields · synced Jun 9, 2026