← Back to catalogue
LensHooke® X3 PRO Semen Quality Analyzer
EUDAMEDFDA 510(k)Class A (EU MDR)
Ref X3 PRO510(k) K242830
Identity
- Trade Name
- LensHooke® X3 PRO Semen Quality Analyzer EUDAMED
- Device Name
- LensHooke® X3 PRO Semen Quality Analyzer EUDAMED
- Model / Reference
- X3 PRO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14719874742673 EUDAMED
- Basic UDI-DI
- 471987474X30QV EUDAMED
- EMDN Code
- W0202059080 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - HARDWARE ACCESSORIES 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® X3 PRO Semen Quality Analyzer 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 | K242830 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 471987474X30QV | Class A | 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 (2)
- EUDAMED 1ff13270-66e6-4ef9-a3ef-37232789499e 85 fields · synced Jun 18, 2026
- FDA 510(k) K242830 1 fields · synced May 18, 2026