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Sperm Morphology Analysis Software
EUDAMEDClass IVD General (EU MDR)
Ref /Model Sanaly-100，Sanaly-200，Sanaly-300
Identity
- Device Name
- Sperm Morphology Analysis Software EUDAMED
- Model / Reference
- Sanaly-100，Sanaly-200，Sanaly-300 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1016B EUDAMED
- Basic UDI-DI
- B-1016B EUDAMED
- EMDN Code
- W02020501 HISTOLOGICAL SAMPLES ANALYSERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 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
No
EUDAMED
Sperm Morphology Analysis Software 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-1016B | Class IVD General | 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 (1)
- EUDAMED 56a2376d-b1ed-47ba-9300-63d4b1d3bb6e 61 fields · synced Jul 11, 2026