Identity
- Trade Name
- Shun Guider EUDAMED
- Device Name
- Introducer Sets EUDAMED
- Model / Reference
- 615930 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956014459300 EUDAMED
- Basic UDI-DI
- B-06956014459300 EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Shun Guider by Shunmei Medical Co., Ltd — Class IIa — 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-06956014459300 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shunmei Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000001160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 50321803-33ab-4faf-ba3f-c51078635b81 61 fields · synced Oct 6, 2026