Identity
- Trade Name
- URIT CA 11 Hematology Calibrator EUDAMED
- Device Name
- Hematology Calibrator EUDAMED
- Model / Reference
- URIT CA 11 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740749565 EUDAMED
- Basic UDI-DI
- 69357407IBHS000026EE EUDAMED
- EMDN Code
- W0103010507 WHOLE BLOOD CALIBRATORS 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 CA 11 Hematology Calibrator 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 | 69357407IBHS000026EE | 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 c0e4b5ed-f1ad-4617-8014-ee58f3042349 61 fields · synced Oct 7, 2026