Identity
- Trade Name
- IDS Prolactin EUDAMEDIDS Prolactin Calibrator Set EUDAMED
- Device Name
- IDS Prolactin EUDAMED
- Model / Reference
- IS-5700 EUDAMEDIS-5720 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169691353 EUDAMED05060169691360 EUDAMED
- Basic UDI-DI
- 5060169691353X6 EUDAMED
- EMDN Code
- W0102050108 PROLACTIN EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Yes
EUDAMED
IDS Prolactin by Immunodiagnostic Systems Limited — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5060169691353X6 | 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 (2)
- EUDAMED bc045bc4-df64-4aa8-810c-8c2e23816f06 61 fields · synced Jul 17, 2026
- EUDAMED 0405ef54-f6ff-4357-9188-b046b3d99979 61 fields · synced May 18, 2026