Identity
- Trade Name
- URIT QC 11 Hematology Control EUDAMED
- Device Name
- Hematology Control EUDAMED
- Model / Reference
- URIT QC 11 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740743433 EUDAMED06935740743426 EUDAMED
- Basic UDI-DI
- 69357407IBHS000025EC 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 QC 11 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 | 69357407IBHS000025EC | 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 (2)
- EUDAMED 1f054d94-d433-40ee-98a2-7f9b18997069 61 fields · synced Oct 6, 2026
- EUDAMED bd793195-a1b1-49ea-8ef1-36d22f9921fa 61 fields · synced May 19, 2026