Identity
- Trade Name
- URIT HQ 60 Hematology Control EUDAMED
- Device Name
- Hematology Control EUDAMED
- Model / Reference
- URIT HQ 60 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740731355 EUDAMED
- Basic UDI-DI
- 69357407IBHS000013E5 EUDAMED
- EMDN Code
- W0103010501 NORMAL BLOOD CONTROLS EUDAMED
Classification
- Device Class
- Class B 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 HQ 60 Hematology Control by URIT Medical Electronic Co., Ltd. — Class B — 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 | 69357407IBHS000013E5 | Class B | 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 (1)
- EUDAMED b09108fa-ec4d-4c6d-ad75-fd9b8434fde7 61 fields · synced Jun 18, 2026