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Semen Sample Dilution Kit
EUDAMEDClass A (EU MDR)
Ref K02003-02Model DIL-S Ref K02003-01
Identity
- Device Name
- Semen Sample Dilution Kit EUDAMED
- Model / Reference
- DIL-S EUDAMEDK02003-02 EUDAMEDK02003-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974675460275 EUDAMED06974675460268 EUDAMED
- Basic UDI-DI
- 697467546802019C 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
Semen Sample Dilution Kit 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 | 697467546802019C | 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 25540da8-49fd-4560-b1bf-569282a906ad 61 fields · synced Jul 23, 2026
- EUDAMED fa05aef8-911f-4dc1-89b2-472f1cf07d36 61 fields · synced May 18, 2026