← Back to catalogue
Hematology Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref iH30 ProRef iH30 ProModel H30 Pro
Identity
- Trade Name
- Hematology Analyzer EUDAMED
- Device Name
- Hematology Analyzer EUDAMED
- Model / Reference
- iH30 Pro EUDAMEDH30 Pro EUDAMEDiH30 Pro EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413814257 EUDAMED
- Basic UDI-DI
- B-06944413814257 EUDAMED69444138H30ProSP9 EUDAMED
- EMDN Code
- W0202010201 AUTOMATED 3 PART HEMATOLOGY ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMEDClass 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 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-06944413814257 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-06944413814257 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edan Instruments, Inc.
- EUDAMED SRN
- CN-MF-000009957
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 4d6b02eb-d044-4974-a83b-4201efeddc22 61 fields · synced Jul 28, 2026
- EUDAMED 261636fd-76db-4cd1-8b3b-e917a24b079d 61 fields · synced May 18, 2026