Identity
- Trade Name
- Shun Armor III EUDAMED
- Device Name
- Hemostasis valve set EUDAMED
- Model / Reference
- 616118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956014461181 EUDAMED
- Basic UDI-DI
- B-06956014461181 EUDAMED
- EMDN Code
- C900101 HAEMOSTASIS VALVES 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 Armor III 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-06956014461181 | 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 488588be-17ff-485a-8e7a-732496194d33 61 fields · synced Sep 18, 2026