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Frend Tsh
EUDAMEDFDA 510(k)FDA UDIClass IVD General (EU MDR)
Ref FRTS 025Model FREND TSH510(k) K131928
Identity
- Trade Name
- FREND TSH EUDAMEDFDA UDI
- Generic Name
- Thyroid stimulating hormone (TSH) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- FRTS 025 EUDAMEDIt is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System. FDA UDI
- Model / Reference
- FREND TSH EUDAMEDFRTS 025 EUDAMEDFDA UDI
- Description
- It is used for the quantitative determination of Thyroid Stimulating Hormone in human specimen using FREND System. FDA UDI
Identifiers
- Catalog Number
- FRTS 025 FDA UDI
- Primary DI / UDI-DI
- 08809317540016 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540016 EUDAMED
- 510(k) Number
- FDA Product Code
- JLW FDA 510(k)FDA UDI
- EMDN Code
- W01020410 THYROID STIMULATING HORMONE EUDAMED
- GMDN Term
- Thyroid stimulating hormone (TSH) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 862.1690 FDA 510(k)
- Regulation Number
- 862.1690 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
EUDAMEDEUDAMED
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 Tsh by NanoEnTek, Inc. — Class IVD General — FDA_510K, IVDD — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131928 | Class IVD General | Active |
| EUDAMED | European Union | CE/IVDD | B-08809317540016 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (4)
- EUDAMED 1e0fcf29-f436-4611-9ec2-6acce879e0ec 61 fields · synced Jul 28, 2026
- FDA 510(k) K131928 24 fields · synced May 18, 2026
- FDA UDI 5743c7cb-79b8-47e4-986a-4d829af57858 35 fields · synced May 29, 2026
- EUDAMED 4eed1dc6-f6fd-4cce-a225-ba5450513b7f 61 fields · synced Jul 28, 2026