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FREND Free T4
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref FRT4AP 020Model FREND Free T4Ref FRT4 020
Identity
- Trade Name
- FREND Free T4 EUDAMEDFDA UDI
- Generic Name
- Free thyroxine (FT4) IVD, reagent FDA UDI
- Device Name
- FRT4AP 020 EUDAMEDFRT4 020 EUDAMEDIt is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System. FDA UDI
- Model / Reference
- FREND Free T4 EUDAMEDFRT4AP 020 EUDAMEDFRT4 020 EUDAMEDFRT4-AP FDA UDIFRT4-HB FDA UDI
- Description
- It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System. FDA UDI
Identifiers
- Catalog Number
- FRT4AP 020 FDA UDIFRT4 020 FDA UDI
- Primary DI / UDI-DI
- 08809317540382 EUDAMEDFDA UDI08809317540191 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540382 EUDAMEDB-08809317540191 EUDAMED
- 510(k) Number
- K152422 FDA UDI
- FDA Product Code
- CEC FDA UDI
- EMDN Code
- W01020402 FREE THYROXINE EUDAMED
- GMDN Term
- Free thyroxine (FT4) IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1695 FDA UDI
- Market of Registration
- Romania EUDAMEDCyprus EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
FREND Free T4 by NanoEnTek, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08809317540382 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (5)
- EUDAMED b0816eea-a560-4668-9be9-4bb534490ec8 61 fields · synced Jul 14, 2026
- EUDAMED fdae8576-febc-44c5-9fcb-103a87aeb009 61 fields · synced May 17, 2026
- FDA UDI 49a894eb-8c19-43e9-a873-81b9d73a80a5 35 fields · synced May 29, 2026
- FDA UDI 44ede2dc-3bdc-418c-a306-5fff6586e4ed 35 fields · synced May 30, 2026
- EUDAMED a4af1108-b947-4682-8be7-35dc0b8c3e66 61 fields · synced Jul 14, 2026