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Sperm Quality Analyzer
EUDAMEDClass IVD General (EU MDR)
Ref /Model RT-S100,RT-S130,RT-S160,RT-S180
Identity
- Device Name
- Sperm Quality Analyzer EUDAMED
- Model / Reference
- RT-S100,RT-S130,RT-S160,RT-S180 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-60201FU EUDAMED
- Basic UDI-DI
- B-60201FU EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Sperm Quality Analyzer by Shenzhen Reetoo Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-60201FU | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shenzhen Reetoo Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000011699
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 29a223be-9896-4f65-bc46-83f5e24c80a3 61 fields · synced Jul 11, 2026