Identity
- Trade Name
- LensHooke X QC Reticle (For Semen) FDA UDI
- Generic Name
- Sperm concentration indicator IVD, control FDA UDI
- Device Name
- 04719874740849 LensHooke X QC Reticle (For Semen)- L0 04719874740856 LensHooke X QC Reticle (For Semen)- L1 04719874740863 LensHooke X QC Reticle (For Semen)- L2 For US FDA UDI
- Model / Reference
- X QC Reticle - 3 in1_US FDA UDI
- Description
- 04719874740849 LensHooke X QC Reticle (For Semen)- L0 04719874740856 LensHooke X QC Reticle (For Semen)- L1 04719874740863 LensHooke X QC Reticle (For Semen)- L2 For US FDA UDI
Identifiers
- Catalog Number
- X QC Reticle FDA UDI
- Primary DI / UDI-DI
- 04719874740832 FDA UDI
- FDA Product Code
- NRF FDA UDI
- GMDN Term
- Sperm concentration indicator IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.8625 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sperm concentration indicator IVD, control
LensHooke X QC Reticle (For Semen) by Bonraybio Co., Ltd. — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bonraybio Co., Ltd.
Sources (2)
- FDA UDI d9f3316c-f3a2-4a5c-9725-b8521875fa5d 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 3, 2026