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Hematology Analyzer
EUDAMEDClass B (EU MDR)
Ref H98SModel H90Ref H96SRef H80Ref H99SRef H90SRef H88S
Identity
- Trade Name
- Hematology Analyzer EUDAMED
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- H90 EUDAMEDH98S EUDAMEDH96S EUDAMEDH80 EUDAMEDH99S EUDAMEDH90S EUDAMEDH88S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413835894 EUDAMED06944413835887 EUDAMED06944413835832 EUDAMED06944413835405 EUDAMED06944413835900 EUDAMED06944413835863 EUDAMED06944413835436 EUDAMED
- Basic UDI-DI
- 69444138H90SPX EUDAMED69444138H80SPS EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Hematology Analyzer 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 | 69444138H90SPX | 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 (7)
- EUDAMED 4ef8bb31-8969-46f0-8d08-379025bd2a6c 61 fields · synced Jul 24, 2026
- EUDAMED affdb8c4-d9ad-4f48-a4f4-387990ac7064 61 fields · synced May 17, 2026
- EUDAMED dcf33717-03d5-41a3-aa2a-a216ff32a544 61 fields · synced May 17, 2026
- EUDAMED 92821277-862b-41b3-addb-d51dd34e9e43 61 fields · synced May 18, 2026
- EUDAMED e5c15a0e-2c90-4da8-b9d6-fc6517501f09 61 fields · synced May 18, 2026
- EUDAMED db706597-062e-4cb9-b485-528eab0845d2 61 fields · synced May 18, 2026
- EUDAMED 2f04fdc8-32df-44b7-8f06-d11b6a2cb1f4 61 fields · synced Jun 20, 2026