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Immunoglobulins E
EUDAMEDClass IVD General (EU MDR)
Ref IEDGX-L00/UDARef IEDGX-B00/CGRRef IEDGX-L00/COBRef IEDGX-H00/AURef IEDGX-B00/AURef IEDGX-B00/COBRef IEDGX-H00/ARCRef IEDGX-H00/UDARef IEDGX-B00/ARCRef IEDGX-B00/ADVRef IEDGX-L00/CGRRef IEDGX-H00/ALIRef IEDGX-L00/AURef IEDGX-L00/ARCRef IEDGX-B00Ref IEDGX-H00/ADVRef IEDGX-B00/UDA
by Diagam S.A.
Identity
- Trade Name
- Immunoglobulins E EUDAMED
- Device Name
- Immunoglobulins E EUDAMED
- Model / Reference
- IEDGX-L00/UDA EUDAMEDIEDGX-B00/CGR EUDAMEDIEDGX-L00/COB EUDAMEDIEDGX-H00/AU EUDAMEDIEDGX-B00/AU EUDAMEDIEDGX-B00/COB EUDAMEDIEDGX-H00/ARC EUDAMEDIEDGX-H00/UDA EUDAMEDIEDGX-B00/ARC EUDAMEDIEDGX-B00/ADV EUDAMEDIEDGX-L00/CGR EUDAMEDIEDGX-H00/ALI EUDAMEDIEDGX-L00/AU EUDAMEDIEDGX-L00/ARC EUDAMEDIEDGX-B00 EUDAMEDIEDGX-H00/ADV EUDAMEDIEDGX-B00/UDA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168015806 EUDAMED05415168010993 EUDAMED05415168015516 EUDAMED05415168006613 EUDAMED05415168006606 EUDAMED05415168015493 EUDAMED05415168009157 EUDAMED05415168006996 EUDAMED05415168009065 EUDAMED05415168008488 EUDAMED05415168011013 EUDAMED05415168008969 EUDAMED05415168013932 EUDAMED05415168009232 EUDAMED05415168006552 EUDAMED05415168008495 EUDAMED05415168007092 EUDAMED
- Basic UDI-DI
- B-05415168015806 EUDAMEDB-05415168010993 EUDAMEDB-05415168015516 EUDAMEDB-05415168006613 EUDAMEDB-05415168006606 EUDAMEDB-05415168015493 EUDAMEDB-05415168009157 EUDAMEDB-05415168006996 EUDAMEDB-05415168009065 EUDAMEDB-05415168008488 EUDAMEDB-05415168011013 EUDAMEDB-05415168008969 EUDAMEDB-05415168013932 EUDAMEDB-05415168009232 EUDAMEDB-05415168006552 EUDAMEDB-05415168008495 EUDAMEDB-05415168007092 EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Immunoglobulins E by Diagam S.A. — 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-05415168015806 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (17)
- EUDAMED 54cd4474-1306-4dea-bcf1-160eb495ad57 61 fields · synced Sep 17, 2026
- EUDAMED 722f9fca-ba1e-4d41-af5d-ff0f09772d10 61 fields · synced May 11, 2026
- EUDAMED bc474464-4fdd-4f94-a6b2-3ed718147eb3 61 fields · synced May 11, 2026
- EUDAMED eafdcec3-3251-4be0-b258-ffe2965214ed 61 fields · synced May 11, 2026
- EUDAMED b49c58ed-ec19-4e74-8cfd-907d6dda109f 61 fields · synced May 16, 2026
- EUDAMED 464c76f5-b3c8-4d72-8318-5f8474341625 61 fields · synced May 16, 2026
- EUDAMED 4f7a75bf-1903-4066-a10b-9f2e7e0a2d9c 61 fields · synced May 16, 2026
- EUDAMED fc17aa44-e1e9-48fc-a10f-4bcf66fc9e06 61 fields · synced May 16, 2026
- EUDAMED e1877291-b443-4145-8c9f-4a4fc70f9b3e 61 fields · synced May 17, 2026
- EUDAMED 2b9ea6e3-bb3f-4d59-9589-2ebcbdee3802 61 fields · synced May 17, 2026
- EUDAMED 97e16e11-76f2-4785-a6e4-db9de5e51525 61 fields · synced May 17, 2026
- EUDAMED 45ae6be8-2d30-4970-b851-9b35235d2f92 61 fields · synced May 17, 2026
- EUDAMED 14251cdb-d4e9-4f6f-af22-01dd1afb722e 61 fields · synced May 17, 2026
- EUDAMED 0011ab86-da62-4358-ab88-ebc7c9144692 61 fields · synced May 17, 2026
- EUDAMED fb95adfd-de20-46cd-a888-6cbad7e940d8 61 fields · synced May 18, 2026
- EUDAMED 8321ec2e-662f-4969-a3e3-291dde41f6f7 61 fields · synced May 18, 2026
- EUDAMED f7bad851-53b5-48f6-89a1-92de1c425bea 61 fields · synced May 18, 2026