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IDS-iSYS 25 VitDS Control Set
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref IS-2530NModel IS-2500N
Identity
- Trade Name
- IDS-iSYS 25 VitDS Control Set EUDAMEDFDA UDI
- Generic Name
- Multiple form 25-hydroxy Vitamin D IVD, control FDA UDI
- Device Name
- IDS-iSYS 25 VitDS EUDAMED
- Model / Reference
- IS-2500N EUDAMEDIS-2530N EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169695306 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060169695283Y6 EUDAMED
- 510(k) Number
- K161831 FDA UDI
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
- GMDN Term
- Multiple form 25-hydroxy Vitamin D IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1660 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
New Device
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 25 VitDS Control Set by Immunodiagnostic Systems Limited — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161831 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 5060169695283Y6 | Class B | Active |
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Manufacturer
- Manufacturer
- Immunodiagnostic Systems Limited
- EUDAMED SRN
- GB-MF-000015851
- Authorised Representative
- Immunodiagnostic Systems SA BE-AR-000015342
Sources (3)
- EUDAMED e957488e-8d61-4c2d-8986-2c56b46b75ef 61 fields · synced Jul 26, 2026
- FDA UDI 4c544b41-8e5c-4e50-98cc-fc799eb952d6 35 fields · synced May 27, 2026
- FDA 510(k) K161831 1 fields · synced May 18, 2026