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ASAHI ZenyteEX PTCA GUIDING CATHETER
EUDAMEDClass III (EU MDR)
Ref W7FL35-2-X100
Identity
- Trade Name
- ASAHI ZenyteEX PTCA GUIDING CATHETER EUDAMED
- Device Name
- ASAHI ZenyteEX PTCA GUIDING CATHETER EUDAMED
- Model / Reference
- W7FL35-2-X100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327079884 EUDAMED
- Basic UDI-DI
- B-04547327079884 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
ASAHI ZenyteEX PTCA GUIDING CATHETER by Asahi Intecc Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04547327079884 | 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 c5f37048-bd4e-4c9a-ae4c-7d44e268e487 61 fields · synced Jun 18, 2026