← Back to catalogue
LensHooke® Sperm Separation Device
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref CA0Model CA0, CA1
Identity
- Trade Name
- LensHooke® Sperm Separation Device EUDAMED
- Device Name
- LensHooke® Sperm Separation Device EUDAMED
- Model / Reference
- CA0, CA1 EUDAMEDCA0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14719874743861 EUDAMED14719874742185 EUDAMED
- Basic UDI-DI
- 471987474CAYT EUDAMEDB-14719874742185 EUDAMED
- Unit of Use DI
- 04719874743864 EUDAMED
- EMDN Code
- U080299 DEVICES FOR ASSISTED REPRODUCTION - OTHER EUDAMEDW05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Surgical Instrument
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
LensHooke® Sperm Separation Device by Bonraybio Co., Ltd. — Class IIb — FDA_510K, IVDD, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221810 | Class IIb | Active |
| EUDAMED | European Union | CE/IVDD | 471987474CAYT | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 471987474CAYT | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bonraybio Co., LTD.
- EUDAMED SRN
- TW-MF-000029512
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 08fc01a7-9d49-4b81-800e-825236768144 61 fields · synced Jul 18, 2026
- EUDAMED 698f673a-93af-499c-b0b6-410632bc8b49 61 fields · synced May 16, 2026
- FDA 510(k) K221810 1 fields · synced May 18, 2026