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Hematology Control
EUDAMEDClass IVD General (EU MDR)
Ref ED-30D Control NRef ED-30D
Identity
- Trade Name
- Hematology Control EUDAMED
- Device Name
- Hematology Control EUDAMED
- Model / Reference
- ED-30D Control N EUDAMEDED-30D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413815766 EUDAMED
- Basic UDI-DI
- B-06944413815766 EUDAMED69444138HematoryCon30DA3 EUDAMED
- EMDN Code
- W0103010503 MULTILEVEL BLOOD CONTROLS 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 Control 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-06944413815766 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06944413815766 | 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 c05d0524-3d7c-4705-9f65-79b2509bcd9c 61 fields · synced Jul 23, 2026
- EUDAMED ab68f976-828a-4fa7-b8c1-42d5cea984aa 61 fields · synced May 19, 2026