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IDS-iSYS 1, 25-Dihydroxy Vitamin D
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref IS-2400
Identity
- Trade Name
- IDS-iSYS 1,25-Dihydroxy Vitamin D EUDAMEDFDA UDI
- Generic Name
- 1,25-Dihydroxy vitamin D3 IVD, reagent FDA UDI
- Device Name
- IDS-iSYS 1,25-Dihydroxy Vitamin D EUDAMED
- Model / Reference
- IS-2400 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690349 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060169690349 EUDAMED
- 510(k) Number
- K123253 FDA UDI
- FDA Product Code
- MRG FDA UDI
- EMDN Code
- W0102060308 1.25-DIHYDROXYVITAMIN D EUDAMED
- GMDN Term
- 1,25-Dihydroxy vitamin D3 IVD, reagent FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1825 FDA UDI
- Market of Registration
- Belgium 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
Yes
EUDAMED
Animal Tissues
Yes
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
IDS-iSYS 1, 25-Dihydroxy Vitamin D by Immunodiagnostic Systems Limited — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-05060169690349 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (2)
- EUDAMED 7906ce53-90de-4386-9b06-c5c18b50193f 61 fields · synced May 29, 2026
- FDA UDI e431cc17-08a3-499c-973e-3b30883c219a 35 fields · synced May 26, 2026