Identity
- Trade Name
- iFlash-Androstenedione EUDAMEDFDA UDI
- Generic Name
- Androstenedione IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-Androstenedione EUDAMED
- Model / Reference
- C86062 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912718055 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270155HF EUDAMED
- FDA Product Code
- CIZ FDA UDI
- EMDN Code
- W0102050101 ANDROSTENEDIONE EUDAMED
- GMDN Term
- Androstenedione IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1075 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
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
iFlash-Androstenedione by Shenzhen Yhlo Biotech Co., Ltd. — Class B — 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 | 692591270155HF | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED dd7199f7-ed8f-4654-907b-f89560a7f879 61 fields · synced Jun 20, 2026
- FDA UDI 8408e2d0-da8c-4e1c-aaf6-e6cb6c76cbb5 32 fields · synced May 29, 2026