Identity
- Trade Name
- Hematology Calibrator EUDAMED
- Device Name
- Hematology Calibrator EUDAMED
- Model / Reference
- ED-CAL PLUS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413814127 EUDAMED
- Basic UDI-DI
- B-06944413814127 EUDAMED69444138HematoryCaliB8 EUDAMED
- EMDN Code
- W0103010507 WHOLE BLOOD CALIBRATORS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
Hematology Calibrator by Edan Instruments, Inc. — Class IVD General — IVDR, IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-06944413814127 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06944413814127 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED a5174885-df2d-4bf2-9ba5-8b83994357a5 61 fields · synced Jul 14, 2026
- EUDAMED acdc6a29-f4d9-4085-80a5-1662dedee305 61 fields · synced May 19, 2026