Identity
- Trade Name
- Hematology control EUDAMED
- Device Name
- Hematology Control EUDAMED
- Model / Reference
- ED-60D EUDAMEDED-60D Control N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413815827 EUDAMED
- Basic UDI-DI
- 69444138HematoryCon60DAJ EUDAMEDB-06944413815827 EUDAMED
- EMDN Code
- W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General 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 B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 69444138HematoryCon60DAJ | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 69444138HematoryCon60DAJ | Class B | 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 20dcbd57-4156-444c-9bef-c16e753309d1 61 fields · synced Aug 5, 2026
- EUDAMED 13249790-eecf-4e5c-9c93-9c8df8363af5 61 fields · synced May 18, 2026