Identity
- Device Name
- Mini Sheath EUDAMED
- Model / Reference
- MI4F05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942033976485 EUDAMED
- Basic UDI-DI
- 69509009MSFB EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Interventional radiology percutaneous-access kit, single-use
Mini Sheath by Shanghai INT Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Interventional radiology percutaneous-access kit, single-use.
- Access Needle — Mermaid Medical A/S · Class I
- EXTesia — Curatia Medical Limited · Class IIa
- SWL-Pathfinder — SWL Medizin GmbH · Class III
- EXTesia — Curatia Medical Limited · Class IIa
- EXTesia — Curatia Medical Limited · Class IIa
- Shun Guider — Shunmei Medical Co.,Ltd · Class IIa
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
- EXTesia — Curatia Medical Limited · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69509009MSFB | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai INT Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000009966
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2f78de1d-9ac6-40c4-a94e-1661e1fedc55 61 fields · synced Jul 9, 2026