Identity
- Trade Name
- Hematology Control EUDAMED
- Device Name
- Hematology Control EUDAMED
- Model / Reference
- ED-90D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413840348 EUDAMED06944413840324 EUDAMED06944413840355 EUDAMED06944413840331 EUDAMED
- Basic UDI-DI
- 69444138HematoryCon90DAZ EUDAMED
- EMDN Code
- W0103010503 MULTILEVEL BLOOD CONTROLS EUDAMED
Classification
- Device Class
- Class 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 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 | 69444138HematoryCon90DAZ | 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 (4)
- EUDAMED 7f80e61f-c8cf-480e-8596-c86858f4fa18 61 fields · synced Jul 25, 2026
- EUDAMED a5e4d6d7-a864-4971-9813-1607e5329104 61 fields · synced May 19, 2026
- EUDAMED 4d946545-2a9d-4165-ba85-89ebdf9d5587 61 fields · synced May 19, 2026
- EUDAMED 914d6100-bd38-48e3-8605-2c5775e71e06 61 fields · synced May 19, 2026