Identity
- Trade Name
- FREND System EUDAMEDFDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
- Device Name
- FREND System EUDAMEDFREND System is designed for reding the FREND cartridge of a quantitative. FDA UDI
- Model / Reference
- FREND System EUDAMEDF10 EUDAMEDFDA UDI
- Description
- FREND System is designed for reding the FREND cartridge of a quantitative. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809317540207 EUDAMEDFDA UDI
- Basic UDI-DI
- 880931754FRENDKQ EUDAMED
- 510(k) Number
- K124056 FDA UDI
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
FREND System by NanoEnTek, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 880931754FRENDKQ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | 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 8d07fd16-ac01-4d4a-9778-320903dfd6eb 61 fields · synced Jul 12, 2026
- FDA UDI 93f981f1-22b6-47a1-9a49-63b89f709ba5 34 fields · synced May 29, 2026