Identity
- Device Name
- Hemostasis Valve EUDAMEDHemostasis Valve Set EUDAMED
- Model / Reference
- HV EUDAMED111001 EUDAMEDHV-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971162811770 EUDAMED
- Basic UDI-DI
- 69368412HV11TY EUDAMEDB-06971162811770 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hemostasis Valve by Tianck Medical Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69368412HV11TY | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69368412HV11TY | 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 (2)
- EUDAMED a3317864-cc63-4a7a-bdc4-f7a10e1c7843 61 fields · synced Oct 6, 2026
- EUDAMED 8a643913-76fb-46d1-8cc3-f256f6ff3560 61 fields · synced May 17, 2026