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Hematology Calibrator
EUDAMEDClass IVD General (EU MDR)
Ref 0320900302Model L-CAL：3mL×1
Identity
- Trade Name
- Hematology Calibrator EUDAMED
- Device Name
- Hematology Calibrator EUDAMED
- Model / Reference
- L-CAL：3mL×1 EUDAMED0320900302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976578180083 EUDAMED
- Basic UDI-DI
- B-06976578180083 EUDAMED
- EMDN Code
- W0103010507 WHOLE BLOOD CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General 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
Hematology Calibrator by Wheisman Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06976578180083 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Wheisman Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000045463
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED bd7eb6ba-0548-4aef-b405-a5cfe2f06e25 61 fields · synced Jul 18, 2026