Identity
- Trade Name
- Sample Diluent EUDAMED
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- 1.0mL EUDAMED0.5mL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975403050027 EUDAMED06975403050010 EUDAMED
- Basic UDI-DI
- 697540305YX3E EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER 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
Category: Nucleic acid extraction/isolation kit IVD
Sample Diluent by HILEAP Medtech (Nantong) Corp. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697540305YX3E | Class A | Active |
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Manufacturer
- Manufacturer
- HILEAP Medtech (Nantong) Corp.
- EUDAMED SRN
- CN-MF-000037836
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 5dd6cf47-e586-4264-8c8b-0910efc23c65 61 fields · synced Jul 8, 2026
- EUDAMED 78fe843c-506c-4376-9189-9c1016698084 61 fields · synced May 19, 2026