Identity
- Trade Name
- Disposable Hemostasis Valve Kits EUDAMED
- Device Name
- Disposable Hemostasis Valve Kits EUDAMED
- Model / Reference
- OM-HV-0202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972985350378 EUDAMED
- Basic UDI-DI
- B-06972985350378 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-06972985350378 | 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 (1)
- EUDAMED d0e19db1-9a09-4a16-8496-3267a083aa55 61 fields · synced Jun 18, 2026