Diluent for Hematology Analysis
by Genegeo Diagnostics (Jiangsu) Co., Ltd. China EUDAMED
Ref 300105010001, 300101010002, 300101010001, 300105010003Model 10-DRS, DXS EMDN W0103010105
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697615409RETDiluent5D | Date21 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- 10-DRS, 300105010001, DXS, 300101010002, 300101010001, 300105010003
- Primary DI / UDI-DI
- 06976154092199, 06976154092120, 06976154092496, 06976154092212
- Basic UDI-DI
- 697615409RETDiluent5D, 697615409DXSDiluent5R
- EMDN Code
- W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
- Device Class
- Class A
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CN-MF-000052709
- Authorised representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
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Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No
Sources (4)
- EUDAMED cc3dbe68-29dd-4160-a1f9-9b66598a45a1
- EUDAMED 06976154092120|697615409DXSDILUENT5R
- EUDAMED 06976154092496|697615409DXSDILUENT5R
- EUDAMED 06976154092212|697615409RETDILUENT5D