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LensHooke® X QC Reticle (For Semen)

EUDAMED

Class A (EU MDR)

Ref X QC ReticleRef CS3 10μm

by Bonraybio Co., LTD.

Identity

Trade Name
LensHooke® EUDAMED
Device Name
LensHooke® X QC Reticle (For Semen) EUDAMED
LensHooke® Semen Test Slide EUDAMED
Model / Reference
X QC Reticle EUDAMED
CS3 10μm EUDAMED

Identifiers

Primary DI / UDI-DI
04719874740917 EUDAMED
04719874740931 EUDAMED
14719874742321 EUDAMED
04719874740948 EUDAMED
Basic UDI-DI
471987474QXAU6 EUDAMED
471987474CS3QP EUDAMED
Direct Marketing DI
04719874740931 EUDAMED
04719874740948 EUDAMED
EMDN Code
W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
W05039080 DEVICES FOR SAMPLES ANALYSES - OTHER ACCESSORIES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Germany EUDAMED
Italy 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

No

EUDAMED

New Device

No

EUDAMED

LensHooke® X QC Reticle (For Semen) 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

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Manufacturer

Manufacturer
Bonraybio Co., LTD.
EUDAMED SRN
TW-MF-000029512
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (4)

  • EUDAMED a56fff15-01d5-4b08-a0c8-684eb1fd02df 61 fields · synced Aug 3, 2026
  • EUDAMED fdb934f8-ed90-45ee-a230-936be168dd35 61 fields · synced May 19, 2026
  • EUDAMED 634eb83d-6448-4225-b822-cfae5bfd5f21 61 fields · synced May 19, 2026
  • EUDAMED 2e9fa776-c229-43dc-81aa-94d0f53f4293 61 fields · synced May 19, 2026