Identity
- Trade Name
- RS1 (HEM-6160-E) EUDAMED
- Device Name
- RS1 EUDAMED
- Model / Reference
- HEM-6160-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672111097 EUDAMED
- Basic UDI-DI
- 4015672111094U EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The RS1 (HEM-6160-E) medical device is a standard-level hemostasis monitor used for real-time monitoring of blood clotting processes. It features a user-friendly interface, accurate results, and compliance with regulatory standards.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4015672111094U | Class IIa | Active |
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Manufacturer
- Manufacturer
- OMRON Healthcare Co., Ltd.
- EUDAMED SRN
- JP-MF-000007213
- Authorised Representative
- OMRON Healthcare Europe B.V. NL-AR-000002683
Sources (1)
- EUDAMED 0e15160e-c57f-4054-8461-aaa696913a01 61 fields · synced Jul 10, 2026