Identity
- Trade Name
- iFlash-T3 EUDAMEDFDA UDI
- Generic Name
- Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- iFlash-T3 EUDAMED
- Model / Reference
- C86025 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06925912718505 EUDAMEDFDA UDI
- Basic UDI-DI
- 692591270004GR EUDAMED
- FDA Product Code
- CDP FDA UDI
- EMDN Code
- W01020405 TRIIODOTHYRONINE EUDAMED
- GMDN Term
- Total triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1710 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 triiodothyronine (TT3) IVD, kit, chemiluminescent immunoassay
iFlash-T3 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 7281cec6-3479-4697-8064-f892419750ce 32 fields · synced Jun 18, 2026
- EUDAMED 72c9d6fa-a9de-45d8-8971-7a97807b4725 61 fields · synced Jun 18, 2026