Identity
- Trade Name
- Disposable Introducer Set EUDAMED
- Device Name
- Disposable Introducer Set EUDAMED
- Model / Reference
- OM-IS10-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985352044 EUDAMED
- Basic UDI-DI
- B-06972985352044 EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Interventional radiology percutaneous-access kit, single-use
Disposable Introducer Set by Ortus Medi-Tech Co., Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06972985352044 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ortus Medi-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000031033
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 4edfa82b-c2f0-48ee-92c8-6e629aa4304b 61 fields · synced Jul 9, 2026