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SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Judkins Right 3.5cm, 100cm
EUDAMEDClass III (EU MDR)
Ref G8JR35-0-L100Ref G8JR35-0-L100SRef G8JR40-0-L100S
Identity
- Trade Name
- SheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Judkins Right 3.5cm, 100cm EUDAMEDSheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Judkins Right 3.5cm, Short Tip, 100cm EUDAMEDSheathLess Eaucath PTCA Guiding Catheter, 8.5 Fr, Judkins Right 4.0cm, Short Tip, 100cm EUDAMED
- Device Name
- SheathLess Eaucath PTCA Guiding Catheter EUDAMED
- Model / Reference
- G8JR35-0-L100 EUDAMEDG8JR35-0-L100S EUDAMEDG8JR40-0-L100S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327083812 EUDAMED04547327083836 EUDAMED04547327083843 EUDAMED
- Basic UDI-DI
- B-04547327083812 EUDAMEDB-04547327083836 EUDAMEDB-04547327083843 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, Judkins Right 3.5cm, 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-04547327083812 | 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 (3)
- EUDAMED 86609606-bc9c-4a4e-88b5-e0b35221ca46 61 fields · synced Oct 6, 2026
- EUDAMED 4aa6a397-ad24-4548-92d8-9d3fbdd84213 61 fields · synced May 19, 2026
- EUDAMED 28f2aded-7fa5-4364-afc2-87f019d5aef2 61 fields · synced May 19, 2026