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Disposable Hemostasis Valve Kits
EUDAMEDClass I (EU MDR)
Ref OM-HV-0302Ref OM-HV-0204
Identity
- Trade Name
- Disposable Hemostasis Valve Kits EUDAMED
- Device Name
- Disposable Hemostasis Valve Kits EUDAMED
- Model / Reference
- OM-HV-0302 EUDAMEDOM-HV-0204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985350415 EUDAMED06972985350392 EUDAMED
- Basic UDI-DI
- B-06972985350415 EUDAMEDB-06972985350392 EUDAMED
- EMDN Code
- C900101 HAEMOSTASIS VALVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Disposable Hemostasis Valve Kits by Ortus Medi-Tech Co., Ltd — Class I — 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-06972985350415 | Class I | Active |
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Manufacturer
- Manufacturer
- Ortus Medi-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000031033
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e9e20f8d-8edf-484b-a4af-5d23bf8034ef 61 fields · synced Jul 26, 2026
- EUDAMED 467efe0b-479b-439d-bc71-33901719c0b1 61 fields · synced May 17, 2026