Identity
- Device Name
- LensHooke® Semen Analysis System EUDAMED
- Model / Reference
- X12 PRO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719874742164 EUDAMED04719874742171 EUDAMED04719874741617 EUDAMED
- Basic UDI-DI
- 471987474X12QT EUDAMED
- Direct Marketing DI
- 04719874741600 EUDAMED
- EMDN Code
- W0202059099 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - OTHER 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
LensHooke® Semen Analysis System by Bonraybio Co., Ltd. — Class A — FDA_510K, IVDR — 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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242388 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 471987474X12QT | 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 (4)
- EUDAMED 65141301-72a3-494f-8aa7-7f61c816b6c2 61 fields · synced Aug 2, 2026
- EUDAMED 5323f9be-abec-4215-8d3c-4b15d9499aa5 61 fields · synced May 17, 2026
- EUDAMED 314fc26a-d7d6-4d36-a671-a162513647be 61 fields · synced May 17, 2026
- FDA 510(k) K242388 1 fields · synced May 18, 2026