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The ASAHI Tornus 2.6 Fr〔88 Flex〕Support Catheter
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref AT35135
Identity
- Trade Name
- The ASAHI Tornus 2.6 Fr〔88 Flex〕Support Catheter EUDAMED
- Device Name
- ASAHI Tornus 2.1Fr support catheter ASAHI Tornus 2.6Fr [88Flex] support catheter EUDAMED
- Model / Reference
- AT35135 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327056939 EUDAMED
- Basic UDI-DI
- B-04547327056939 EUDAMED
- EMDN Code
- C01050201 PTCA EMBOLIC PROTECTION CATHETERS AND SYSTEMS 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
The ASAHI Tornus 2.6 Fr〔88 Flex〕Support Catheter by Asahi Intecc Co., Ltd. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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 | K051772 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-04547327056939 | 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 dff62a71-9020-41b6-9eda-0fdd4df60281 61 fields · synced Jul 16, 2026
- FDA 510(k) K051772 1 fields · synced May 18, 2026