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IDS Cortisol Control Set
EUDAMEDFDA UDIClass B (EU MDR)
Ref IS-4630Model IS-4600
Identity
- Trade Name
- IDS Cortisol Control Set EUDAMEDFDA UDI
- Generic Name
- Total cortisol IVD, control FDA UDI
- Device Name
- IDS Cortisol EUDAMED
- Model / Reference
- IS-4600 EUDAMEDIS-4630 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690820 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060169690691XN EUDAMED
- FDA Product Code
- JJX FDA UDI
- EMDN Code
- W0102152008 CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES EUDAMED
- GMDN Term
- Total cortisol 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
IDS Cortisol Control Set by Immunodiagnostic Systems Limited — Class B — 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 | 5060169690691XN | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | 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 e63dc957-9b8c-4f1c-b915-2ae7271c1306 61 fields · synced Jun 19, 2026
- FDA UDI d8b0c115-fb42-44f9-8f83-a4fc45e10141 34 fields · synced May 30, 2026