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LensHooke® Sperm DNA Fragmentation Rapid Test Kit (SCD Assay)
EUDAMEDClass A (EU MDR)
Ref R10 PlusModel R10
Identity
- Trade Name
- LensHooke® Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) EUDAMED
- Device Name
- LensHooke® Sperm DNA Fragmentation Test Kit (SCD Assay) EUDAMED
- Model / Reference
- R10 EUDAMEDR10 Plus EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14719874742789 EUDAMED
- Basic UDI-DI
- 471987474R10PR EUDAMED
- EMDN Code
- W0103010302 ROMANOWSKY STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
LensHooke® Sperm DNA Fragmentation Rapid Test Kit (SCD Assay) by Bonraybio 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 | 471987474R10PR | Class A | Active |
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Manufacturer
- Manufacturer
- Bonraybio Co., LTD.
- EUDAMED SRN
- TW-MF-000029512
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 248e14c2-beb7-4206-8695-2b50701ac70b 61 fields · synced May 22, 2026