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IDS-iSYS Ostase® BAP Control Set
EUDAMEDClass IVD General (EU MDR)
Ref IS-2830Ref IS-2800
Identity
- Trade Name
- IDS-iSYS Ostase® BAP Control Set EUDAMEDIDS-iSYS Ostase® BAP EUDAMED
- Device Name
- IDS-iSYS Ostase® BAP Control Set EUDAMEDIDS-iSYS Ostase® BAP EUDAMED
- Model / Reference
- IS-2830 EUDAMEDIS-2800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060169690219 EUDAMED05060169690202 EUDAMED
- Basic UDI-DI
- B-05060169690219 EUDAMEDB-05060169690202 EUDAMED
- EMDN Code
- W0102152003 SPECIFIC PROTEIN CONTROLS EUDAMEDW0102060399 BONE METABOLISM TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
IDS-iSYS Ostase® BAP Control Set by Immunodiagnostic Systems Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-05060169690219 | Class IVD General | 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 d0716afa-1a17-478e-8021-eca076f2f51b 61 fields · synced Jul 16, 2026
- EUDAMED cd265189-0cca-464e-81a2-e0783ad657ce 61 fields · synced May 18, 2026