Identity
- Trade Name
- Kosen EUDAMED
- Device Name
- Hemostasis Valve Set EUDAMED
- Model / Reference
- HV-02 EUDAMED111002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936841204007 EUDAMED
- Basic UDI-DI
- B-06936841204007 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
Kosen by Tianck 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-06936841204007 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tianck Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000007451
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 0257352d-4819-4666-bd28-920ef9f11a4b 61 fields · synced Jun 11, 2026