Identity
- Trade Name
- Diluent EUDAMED
- Device Name
- Diluent EUDAMED
- Model / Reference
- HD310 EUDAMEDHD93R EUDAMEDHD600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944413814042 EUDAMED06944413836204 EUDAMED06944413813502 EUDAMED06944413836181 EUDAMED06944413814059 EUDAMED
- Basic UDI-DI
- 69444138HD310HM EUDAMED69444138HD93RLT EUDAMED69444138HD600HZ EUDAMED
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Diluent by Edan Instruments, Inc. — Class A — 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 | 69444138HD310HM | Class A | 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 (5)
- EUDAMED b9f8ad1e-0ccc-4d59-a1d6-70c20780fc83 61 fields · synced Jul 29, 2026
- EUDAMED de36c146-e036-42e0-a425-85e6cb8594ea 61 fields · synced May 17, 2026
- EUDAMED 59f0e2fd-7b30-4644-b893-6bddcc1d7594 61 fields · synced May 18, 2026
- EUDAMED 914c0452-111f-43ac-b52a-f432357a28e5 61 fields · synced May 19, 2026
- EUDAMED a0be2013-1f53-4fc3-8136-d723ed3d4468 61 fields · synced May 19, 2026