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IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent
EUDAMEDClass IVD General (EU MDR)
Ref 447020
Identity
- Trade Name
- IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent EUDAMED
- Device Name
- IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent EUDAMED
- Model / Reference
- 447020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-447020PE EUDAMED
- Basic UDI-DI
- B-447020PE EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland 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
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent by Beckman Coulter, Inc. — Class IVD General — IVDD — listed in EUDAMED
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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-447020PE | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Inc.
- EUDAMED SRN
- US-MF-000010288
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (1)
- EUDAMED 541a966a-7420-4610-ae92-f0ac323209c1 61 fields · synced Oct 6, 2026