Identity
- Trade Name
- iFlash-FSH EUDAMEDFDA UDI
- Generic Name
- Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-FSH EUDAMED
- Model / Reference
- C86011 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912718499 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270012GQ EUDAMED
- FDA Product Code
- CGJ FDA UDI
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
- GMDN Term
- Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
iFlash-FSH by Shenzhen YHLO Biotech Co., Ltd. — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay.
- Elecsys FSH — Roche Diagnostics Corp. · Class I
- FSH AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class I
- Elecsys FSH — Roche Diagnostics Corp. · Class I
- Monobind AccuLite FSH, hCG, LH & PRLs VAST CLIA Kit - 480 Wells — MONOBIND, INC. · Class I
- ARCHITECT — ABBOTT IRELAND · Class I
- LIAISON FSH — Diasorin Inc.
- IMMULITE® 2000 Systems FSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- IMMULITE 2000 FSH Kit Domestic 200T — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen YHLO Biotech Co., Ltd.
Sources (2)
- FDA UDI 2ab93543-493f-452f-999f-c2eb93534ccd 32 fields · synced Jul 20, 2026
- EUDAMED c7c8b4ff-c0c1-4360-b562-9db77a584748 61 fields · synced Jul 20, 2026