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SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Amplatz Left 1.0, 100cm
EUDAMEDClass III (EU MDR)
Ref G8AL10-0-L100
Identity
- Trade Name
- SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Amplatz Left 1.0, 100cm EUDAMED
- Device Name
- SheathLess Eaucath PTCA Guiding Catheter EUDAMED
- Model / Reference
- G8AL10-0-L100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327083850 EUDAMED
- Basic UDI-DI
- B-04547327083850 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, Amplatz Left 1.0, 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-04547327083850 | 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 (1)
- EUDAMED 26d47991-a90c-43ad-bb32-d30f7456c5a1 61 fields · synced Jul 19, 2026