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IDS-iSYS 17-OH Progesterone
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref IS-5100
Identity
- Trade Name
- IDS-iSYS 17-OH Progesterone EUDAMEDFDA UDI
- Generic Name
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IDS-iSYS 17-OH Progesterone EUDAMED
- Model / Reference
- IS-5100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060169690738 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060169690738 EUDAMED
- FDA Product Code
- JLS FDA UDI
- EMDN Code
- W0102050106 PROGESTERONE EUDAMED
- GMDN Term
- Progesterone IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1620 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
Yes
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 17-OH Progesterone 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-05060169690738 | 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 949cd510-4907-4a5f-9f4e-5f14f0a0090a 61 fields · synced Jul 9, 2026
- FDA UDI cb001841-fe30-40ac-81bd-8c5f51db185b 34 fields · synced May 30, 2026