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SheathLessPV, 6 Fr, Standard, Straight, 55cm
EUDAMEDClass IIa (EU MDR)
Ref W8ST00-0-V055
Identity
- Trade Name
- SheathLessPV, 6 Fr, Standard, Straight, 55cm EUDAMED
- Device Name
- SheathLessPV Peri-Vascular Guiding System EUDAMED
- Model / Reference
- W8ST00-0-V055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547327083102 EUDAMED
- Basic UDI-DI
- B-04547327083102 EUDAMED
- EMDN Code
- C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS 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
SheathLessPV, 6 Fr, Standard, Straight, 55cm by Asahi Intecc Co., Ltd. — Class IIa — 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-04547327083102 | 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 (1)
- EUDAMED 3817b72b-bd83-4514-9d61-191ba29b8366 61 fields · synced Jun 18, 2026