Identity
- Trade Name
- HTI Diluent EUDAMED
- Device Name
- HTI Diluent EUDAMED
- Model / Reference
- 11-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860008666321 EUDAMED
- Basic UDI-DI
- 08600086663HEREDILCN EUDAMED
- Direct Marketing DI
- 00860008666321 EUDAMED
- EMDN Code
- W0202010185 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy 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
HTI Diluent by High Technology 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 | 08600086663HEREDILCN | Class A | Active |
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Manufacturer
- Manufacturer
- High Technology Inc.
- EUDAMED SRN
- US-MF-000036184
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 7f5965b6-f849-4abc-b1c3-c2aceca6efa2 61 fields · synced Jun 19, 2026