Identity
- Trade Name
- ASAHI Tellus EUDAMEDASAHI Tellus Microcatheter EUDAMED
- Device Name
- Masters PARKWAY HF Microcatheter, Masters PARKWAY SOFT Microcatheter, ASAHI Veloute Microcatheter, ASAHI Tellus Microcatheter EUDAMEDASAHI Veloute/ASAHI Tellus EUDAMED
- Model / Reference
- TLS125-16S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327136488 EUDAMED
- Basic UDI-DI
- 4547327BMC009LB EUDAMEDB-04547327136488 EUDAMED
- EMDN Code
- C0104020202 PERIPHERAL EMBOLISATION CATHETERS AND MICROCATHETERS 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 Tellus 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 | 4547327BMC009LB | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4547327BMC009LB | 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 (2)
- EUDAMED e21f428e-87f1-46fe-ae79-5770bb4cf30a 61 fields · synced Sep 18, 2026
- EUDAMED a1ec38ce-a696-4667-898e-bc500db2c649 61 fields · synced May 19, 2026