Identity
- Trade Name
- Shun Window® EUDAMED
- Device Name
- Guiding Catheter EUDAMED
- Model / Reference
- 630604 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956014406045 EUDAMED
- Basic UDI-DI
- B-06956014406045 EUDAMED
- EMDN Code
- C0104010202 CARDIAC ANGIOGRAPHY GUIDE CATHETERS EUDAMED
Classification
- Device Class
- Class III 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 Window® by Shunmei Medical Co., Ltd — Class III — 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-06956014406045 | Class III | 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 129cf966-2a0d-4eed-90a7-f30aa871025e 61 fields · synced Sep 18, 2026