Identity
- Trade Name
- iFlash-DHEA-S EUDAMEDFDA UDI
- Generic Name
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-DHEA-S EUDAMED
- Model / Reference
- C86033 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912718550 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270019H6 EUDAMED
- FDA Product Code
- JKC FDA UDI
- EMDN Code
- W0102050102 DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA) EUDAMED
- GMDN Term
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1245 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
No
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: Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
iFlash-DHEA-S 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 Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay.
- Elecsys DHEA-S — Roche Diagnostics Corp. · Class I
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- ARCHITECT — Abbott · Class I
- Elecsys DHEA-S — Roche Diagnostics Corp. · Class I
- DHEA-S ELISA — DRG International, Inc. · Class I
- IMMULITE®/IMMULITE® 1000 Systems DHS DHEA-SO4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- DHEA-S ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · 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 |
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Manufacturer
- Manufacturer
- Shenzhen YHLO Biotech Co., Ltd.
Sources (2)
- FDA UDI 3929b152-4dc9-47f3-bd5d-ca3b28268978 32 fields · synced Jun 19, 2026
- EUDAMED a208cf43-ee63-486d-a74d-48a36099ac16 61 fields · synced Jun 19, 2026