Identity
- Device Name
- Sample Diluent EUDAMED
- Model / Reference
- DIL-F EUDAMEDC00001-01 EUDAMEDC00001-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974675460237 EUDAMED06974675460244 EUDAMED
- Basic UDI-DI
- 697467546803009F EUDAMED
- EMDN Code
- W01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) 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
Sample Diluent by Shenzhen Reetoo Biotechnology Co., Ltd — 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 | 697467546803009F | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED 6cd7ad95-7666-45fe-81f1-7ec78793298b 61 fields · synced Jul 13, 2026
- EUDAMED a276d181-2c0f-4a40-896e-6aa33349bb9c 61 fields · synced May 19, 2026