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Disposable Hemostasis Valve Kits
EUDAMEDClass I (EU MDR)
Ref OM-HV-0103Ref OM-HV-0201Ref OM-HV-0203Ref OM-HV-0301Ref OM-HV-0304Ref OM-HV-0104
Identity
- Trade Name
- Disposable Hemostasis Valve Kits EUDAMED
- Device Name
- Disposable Hemostasis Valve Kits EUDAMED
- Model / Reference
- OM-HV-0103 EUDAMEDOM-HV-0201 EUDAMEDOM-HV-0203 EUDAMEDOM-HV-0301 EUDAMEDOM-HV-0304 EUDAMEDOM-HV-0104 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985350347 EUDAMED06972985350361 EUDAMED06972985350385 EUDAMED06972985350408 EUDAMED06972985350439 EUDAMED06972985350354 EUDAMED
- Basic UDI-DI
- B-06972985350347 EUDAMEDB-06972985350361 EUDAMEDB-06972985350385 EUDAMEDB-06972985350408 EUDAMEDB-06972985350439 EUDAMEDB-06972985350354 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-06972985350347 | 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 (6)
- EUDAMED 7ec5a258-61a6-46d4-84f1-ffca874d8b86 61 fields · synced Aug 3, 2026
- EUDAMED e6b385f4-7dc4-495a-817e-6f28d9b7eddc 61 fields · synced May 17, 2026
- EUDAMED 00a46715-7d10-4689-8605-654c72c87dac 61 fields · synced May 17, 2026
- EUDAMED 36a6a10c-6b6e-43aa-81e3-08d2378f9649 61 fields · synced May 17, 2026
- EUDAMED 0c7ea45a-d90a-47ff-86e5-cc86ad97f056 61 fields · synced May 17, 2026
- EUDAMED 2faaf353-a291-4e1c-b18b-37dc6b780ad8 61 fields · synced May 17, 2026