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ASAHI SASUKE Double Lumen Catheter (RX/OTW)
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref SA145-33N
Identity
- Trade Name
- ASAHI SASUKE Double Lumen Catheter (RX/OTW) EUDAMED
- Device Name
- ASAHI SASUKE Double Lumen Catheter (RX/OTW) EUDAMED
- Model / Reference
- SA145-33N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327120180 EUDAMED
- Basic UDI-DI
- B-04547327120180 EUDAMED
- EMDN Code
- C0104010203 PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRACORONARY AND INTRACARDIAC CATHETERS EUDAMED
Classification
- Device Class
- Class III 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 SASUKE Double Lumen Catheter (RX/OTW) by Asahi Intecc Co., Ltd. — Class III — 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 | K182844 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327120180 | Class III | 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 9651b0ab-4e6c-4a83-968a-a193351bab5e 61 fields · synced Jul 18, 2026
- FDA 510(k) K182844 1 fields · synced May 18, 2026