Identity
- Trade Name
- iFlash-T4 EUDAMEDFDA UDI
- Generic Name
- Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-T4 EUDAMED
- Model / Reference
- C86026-L EUDAMEDC86026 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912715382 EUDAMED06925912718512 FDA UDI
- Basic UDI-DI
- 692591270005GT EUDAMED
- FDA Product Code
- KLI FDA UDI
- EMDN Code
- W01020407 THYROXINE EUDAMED
- GMDN Term
- Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1700 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: Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
iFlash-T4 by Shenzhen YHLO Biotech 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
IVDR
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
- Shenzhen YHLO Biotech Co., Ltd.
Sources (2)
- FDA UDI a3cbe608-e629-48b9-a2cb-99a382c939a0 32 fields · synced Jul 10, 2026
- EUDAMED eeb363c7-8e8a-4904-86d7-2032059a79b5 61 fields · synced Jul 10, 2026