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FREND Testosterone
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref FRTEAP 020Model FREND Testosterone
Identity
- Trade Name
- FREND Testosterone EUDAMEDFDA UDI
- Generic Name
- Total testosterone IVD, reagent FDA UDI
- Device Name
- FRTEAP 020 EUDAMEDIt is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample. FDA UDI
- Model / Reference
- FREND Testosterone EUDAMEDFRTEAP 020 EUDAMEDFRTE-AP FDA UDI
- Description
- It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample. FDA UDI
Identifiers
- Catalog Number
- FRTEAP 020 FDA UDI
- Primary DI / UDI-DI
- 08809317540375 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540375 EUDAMED
- 510(k) Number
- K153577 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
- GMDN Term
- Total testosterone IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1680 FDA UDI
- Market of Registration
- Germany 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
EUDAMED
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 Testosterone 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-08809317540375 | 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 (2)
- EUDAMED 1d73c5eb-8cac-4191-ae8c-bfe8c44b3d2c 61 fields · synced Jun 8, 2026
- FDA UDI 26ed69ee-1a18-4940-873a-9acdb3f9a2da 35 fields · synced May 30, 2026