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LensHooke® X QC Video (For Semen)
EUDAMEDFDA UDIClass A (EU MDR)
Ref X QC Video
Identity
- Trade Name
- LensHooke X QC Video (For Semen) FDA UDI
- Generic Name
- Sperm concentration indicator IVD, control FDA UDI
- Device Name
- LensHooke® X QC Video (For Semen) EUDAMED
- Model / Reference
- X QC Video EUDAMEDQXB V2 package FDA UDI
Identifiers
- Catalog Number
- X QC Video FDA UDI
- Primary DI / UDI-DI
- 04719874741051 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987474QXBU8 EUDAMED
- Direct Marketing DI
- 04719874741051 EUDAMED
- FDA Product Code
- NRF FDA UDI
- EMDN Code
- W05039099 DEVICES FOR SAMPLES ANALYSES - OTHER EUDAMED
- GMDN Term
- Sperm concentration indicator IVD, control FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
LensHooke® X QC Video (For Semen) by Bonraybio Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 471987474QXBU8 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Bonraybio Co., LTD.
- EUDAMED SRN
- TW-MF-000029512
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 4931acd0-ba01-4026-af06-6a0b75d187c5 61 fields · synced Jul 14, 2026
- FDA UDI db5858e4-849b-428a-be64-9bc8c4eaa865 33 fields · synced May 30, 2026