Identity
- Trade Name
- URIT 5L 11 Lyse EUDAMED
- Device Name
- Lyse EUDAMED
- Model / Reference
- URIT 5L 11 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740723183 EUDAMED06935740723190 EUDAMED
- Basic UDI-DI
- 69357407IBHS000034ED EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
URIT 5L 11 Lyse by URIT Medical Electronic Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69357407IBHS000034ED | Class A | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 20f02071-9bbf-4213-9e06-ab58fb432dfb 61 fields · synced Oct 6, 2026
- EUDAMED f7bdf8f3-342b-4cc9-9f02-350693cfbd89 61 fields · synced May 19, 2026