Identity
- Device Name
- Guiding Sheath EUDAMED
- Model / Reference
- VSM8F04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950900997471 EUDAMED
- Basic UDI-DI
- 69509009VSG6 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED 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: Vascular catheter introduction set, nonimplantable
Guiding Sheath by Shanghai INT Medical Instruments Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 69509009VSG6 | Class IIa | Active |
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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 63c4e387-050f-4e00-862c-1393edb44490 61 fields · synced Jul 26, 2026