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SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Super Power Backup 4.0, 100cm
EUDAMEDClass III (EU MDR)
Ref G8SP40-0-L100Ref G8SP35-0-L100
Identity
- Trade Name
- SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Super Power Backup 4.0, 100cm EUDAMEDSheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Super Power Backup 3.5, 100cm EUDAMED
- Device Name
- SheathLess Eaucath PTCA Guiding Catheter EUDAMED
- Model / Reference
- G8SP40-0-L100 EUDAMEDG8SP35-0-L100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327083874 EUDAMED04547327083867 EUDAMED
- Basic UDI-DI
- B-04547327083874 EUDAMEDB-04547327083867 EUDAMED
- EMDN Code
- C0104010202 CARDIAC ANGIOGRAPHY GUIDE 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
SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Super Power Backup 4.0, 100cm by Asahi Intecc Co., Ltd. — Class III — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04547327083874 | 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 0af4dfd5-e5d6-4597-a95b-43f14f702e4e 61 fields · synced Jul 31, 2026
- EUDAMED f7da9006-de98-4c00-a5b1-a0cc3b7bd260 61 fields · synced May 17, 2026