Identity
- Trade Name
- FREND hsCRP EUDAMED
- Device Name
- FRhCR 025 EUDAMED
- Model / Reference
- FREND hsCRP EUDAMEDFRhCR 025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809317540962 EUDAMED
- Basic UDI-DI
- B-08809317540962 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
FREND hsCRP by NanoEnTek, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08809317540962 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NanoEntek, Inc.
- EUDAMED SRN
- KR-MF-000021903
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED a830857e-9f74-42ef-aed9-72b1c605babb 61 fields · synced Jul 11, 2026
- EUDAMED f419bb41-9731-4f4a-8027-60a29b80a17a 61 fields · synced Jul 11, 2026