Identity
- Trade Name
- KEISEI Vascular Dilators 11cm φ0.05mm EUDAMED
- Device Name
- KEISEI Vascular Dilators 11cm φ0.05mm EUDAMED
- Model / Reference
- SVF05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 34946279746409 EUDAMED
- Basic UDI-DI
- B-34946279746409 EUDAMED
- EMDN Code
- L03130499 GRASPING FORCEPS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
KEISEI Vascular Dilators 11cm φ0.05mm by Keisei Medical Industrial Co., Ltd. — Class I — 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-34946279746409 | Class I | Active |
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Manufacturer
- Manufacturer
- Keisei Medical Industrial Co., Ltd.
- EUDAMED SRN
- JP-MF-000021775
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 7fc6c75f-100c-4bfe-b9d8-47a059ef0c7b 61 fields · synced Jun 19, 2026