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FREND Vitamin D
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref FRVDAP 020Model FREND Vitamin D
Identity
- Trade Name
- FREND Vitamin D EUDAMEDFDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, reagent FDA UDI
- Device Name
- FRVDAP 020 EUDAMEDIt is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma. FDA UDI
- Model / Reference
- FREND Vitamin D EUDAMEDFRVDAP 020 EUDAMEDFRVD-AP FDA UDI
- Description
- It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma. FDA UDI
Identifiers
- Catalog Number
- FRVDAP 020 FDA UDI
- Primary DI / UDI-DI
- 08809317540337 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809317540337 EUDAMED
- 510(k) Number
- K162754 FDA UDI
- FDA Product Code
- MRG FDA UDI
- EMDN Code
- W0102060309 25-HYDROXYVITAMIN D EUDAMED
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1825 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 Vitamin D 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-08809317540337 | 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 7e809a7e-d2e9-43bd-bd58-e04e6376dae8 61 fields · synced May 30, 2026
- FDA UDI 2cd1bbce-f7b7-4e9d-9c22-cf6192fe423d 35 fields · synced May 30, 2026