Identity
- Trade Name
- Beurer FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Beurer Fertility Convenience Kit with Pearl App Each kit contains: 15 FSH test strips, 15 LH test strips, 2 hCG test strips (pregnancy test), Access (activation code) for the Pearl Fertility App. FDA UDI
- Model / Reference
- OT80 FDA UDI
- Description
- Beurer Fertility Convenience Kit with Pearl App Each kit contains: 15 FSH test strips, 15 LH test strips, 2 hCG test strips (pregnancy test), Access (activation code) for the Pearl Fertility App. FDA UDI
Identifiers
- Catalog Number
- 792.97 FDA UDI
- Primary DI / UDI-DI
- 00850003500478 FDA UDI
- FDA Product Code
- LHD FDA UDILCX FDA UDINGE FDA UDINGA FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 862.1155 FDA UDI862.1485 FDA UDI862.1300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, clinicalLuteinizing hormone (LH) IVD, kit, rapid ICT, clinicalFollicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing
Beurer by Beurer North America, L.p. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Follicle stimulating hormone (FSH) IVD, kit, rapid ICT, self-testing.
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- Vivoo — VIVOSENS INC · Class I
- GenaCheck® FSH At-Home Menopause Test — Genabio Diagnostics Inc. · Class I
- Wondfo — WONDFO USA CO., LTD. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Beurer North America, L.p.
Sources (1)
- FDA UDI 0eb3364c-02e7-4473-b482-c791821499c8 34 fields · synced May 30, 2026