Identity
- Device Name
- Sheath introducer EUDAMED
- Model / Reference
- CS-0611 EUDAMEDCS-0511 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972197831313 EUDAMED06972197831290 EUDAMED
- Basic UDI-DI
- B-06972197831313 EUDAMEDB-06972197831290 EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa 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: Vascular catheter introduction set, nonimplantable
Sheath introducer by Shenzhen MicroApproach Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter introduction set, nonimplantable.
- VYGON — Vygon Corp. · Class II
- OneStic Micro-Access Introducer — Argon Medical Devices, Inc. · Class II
- Prelude EASE™ — Merit Medical Systems, Inc. · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
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-06972197831313 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen MicroApproach Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032012
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 40cc3591-a5ec-4fdf-9001-73d41cd2106b 61 fields · synced Jul 22, 2026
- EUDAMED 79c06372-4fee-48c7-a97a-338f17833b86 61 fields · synced May 17, 2026