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LensHooke® X1 PRO Semen Quality Analyzer
EUDAMEDFDA 510(k)Class A (EU MDR)
Ref X1 PRO510(k) K180343
Identity
- Device Name
- LensHooke® X1 PRO Semen Quality Analyzer EUDAMED
- Model / Reference
- X1 PRO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719874740559 EUDAMED
- Basic UDI-DI
- 471987474X10QP 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® X1 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
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 | K202089 | Class A | Active |
| FDA 510(k) | United States | FDA_510K | K180343 | Class A | Active |
| EUDAMED | European Union | CE/IVDR | 471987474X10QP | 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 (2)
- EUDAMED 8eb267a7-c827-40bc-871e-8bed9069682b 85 fields · synced Jun 18, 2026
- FDA 510(k) K202089 1 fields · synced May 18, 2026