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Beta2-microglobulin urine
EUDAMEDClass IVD General (EU MDR)
Ref BUDGX-L00Ref B2DGX-H00/UDARef BUDGX-B00/ALIRef BUDGX-H00/CGRRef B2DGX-B00/AURef B2DGX-L00/CGRRef B2DGX-L00/COBRef B2DGX-B00Ref BUDGX-H00/ADVRef BUDGX-L00/CGRRef B2DGX-H00/ALIRef BUDGX-H00/ALIRef BUDGX-H00/ATERef B2DGX-H00/AURef BUDGX-B00/ARCRef BUDGX-H00/COBRef BUDGX-L00/UDARef BUDGX-B00/ADVRef BUDGX-L00/ATERef B2DGX-L00/ARCRef B2DGX-B00/UDARef BUDGX-H00/UDARef B2DGX-B00/ALIRef B2DGX-L00/ALIRef BUDGX-L00/AURef B2DGX-L00/UDARef B2DGX-H00/ARCRef B2DGX-H00/ATERef BUDGX-H00/ARCRef B2DGX-B00/ATE
by Diagam S.A.
Identity
- Trade Name
- Beta2-microglobulin urine EUDAMEDBeta2-microglobulin EUDAMED
- Device Name
- Beta2-microglobulin urine EUDAMEDBeta2-microglobulin EUDAMED
- Model / Reference
- BUDGX-L00 EUDAMEDB2DGX-H00/UDA EUDAMEDBUDGX-B00/ALI EUDAMEDBUDGX-H00/CGR EUDAMEDB2DGX-B00/AU EUDAMEDB2DGX-L00/CGR EUDAMEDB2DGX-L00/COB EUDAMEDB2DGX-B00 EUDAMEDBUDGX-H00/ADV EUDAMEDBUDGX-L00/CGR EUDAMEDB2DGX-H00/ALI EUDAMEDBUDGX-H00/ALI EUDAMEDBUDGX-H00/ATE EUDAMEDB2DGX-H00/AU EUDAMEDBUDGX-B00/ARC EUDAMEDBUDGX-H00/COB EUDAMEDBUDGX-L00/UDA EUDAMEDBUDGX-B00/ADV EUDAMEDBUDGX-L00/ATE EUDAMEDB2DGX-L00/ARC EUDAMEDB2DGX-B00/UDA EUDAMEDBUDGX-H00/UDA EUDAMEDB2DGX-B00/ALI EUDAMEDB2DGX-L00/ALI EUDAMEDBUDGX-L00/AU EUDAMEDB2DGX-L00/UDA EUDAMEDB2DGX-H00/ARC EUDAMEDB2DGX-H00/ATE EUDAMEDBUDGX-H00/ARC EUDAMEDB2DGX-B00/ATE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05415168007825 EUDAMED05415168003759 EUDAMED05415168006132 EUDAMED05415168010528 EUDAMED05415168001151 EUDAMED05415168010504 EUDAMED05415168002745 EUDAMED05415168000147 EUDAMED05415168005715 EUDAMED05415168010535 EUDAMED05415168006002 EUDAMED05415168006149 EUDAMED05415168006965 EUDAMED05415168001168 EUDAMED05415168005722 EUDAMED05415168005753 EUDAMED05415168015851 EUDAMED05415168005708 EUDAMED05415168009683 EUDAMED05415168002134 EUDAMED05415168003742 EUDAMED05415168016049 EUDAMED05415168006118 EUDAMED05415168006125 EUDAMED05415168013697 EUDAMED05415168003766 EUDAMED05415168002127 EUDAMED05415168007191 EUDAMED05415168005739 EUDAMED05415168009669 EUDAMED
- Basic UDI-DI
- B-05415168007825 EUDAMEDB-05415168003759 EUDAMEDB-05415168006132 EUDAMEDB-05415168010528 EUDAMEDB-05415168001151 EUDAMEDB-05415168010504 EUDAMEDB-05415168002745 EUDAMEDB-05415168000147 EUDAMEDB-05415168005715 EUDAMEDB-05415168010535 EUDAMEDB-05415168006002 EUDAMEDB-05415168006149 EUDAMEDB-05415168006965 EUDAMEDB-05415168001168 EUDAMEDB-05415168005722 EUDAMEDB-05415168005753 EUDAMEDB-05415168015851 EUDAMEDB-05415168005708 EUDAMEDB-05415168009683 EUDAMEDB-05415168002134 EUDAMEDB-05415168003742 EUDAMEDB-05415168016049 EUDAMEDB-05415168006118 EUDAMEDB-05415168006125 EUDAMEDB-05415168013697 EUDAMEDB-05415168003766 EUDAMEDB-05415168002127 EUDAMEDB-05415168007191 EUDAMEDB-05415168005739 EUDAMEDB-05415168009669 EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN 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
Category: Beta-2-microglobulin IVD, reagent
Beta2-microglobulin urine by Diagam S.A. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Beta-2-microglobulin IVD, reagent.
- Beta 2 Microglobulin (β2-MG) Test Kit (Immunofluorescence Method) — WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · IVD General
- Omlipo BMG Kit — Goldsite Diagnostics Inc. · IVD General
- Optilite® Beta-2 Microglobulin Urine Control Pack — The Binding Site Group Ltd. · Class B
- ReLIA — ReLIA Biotechnologies (Jiangsu), Inc. · IVD General
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-05415168007825 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Diagam S.A.
- EUDAMED SRN
- BE-MF-000022993
Sources (30)
- EUDAMED 4b992e74-5cf9-47cf-8d56-a0c9c80ebf11 61 fields · synced Aug 4, 2026
- EUDAMED e724a586-21a8-4670-8584-62e310eb9974 61 fields · synced May 11, 2026
- EUDAMED a16a3810-7f27-4f57-b3d6-c850f9a86958 61 fields · synced May 16, 2026
- EUDAMED 2197a24e-bd59-458f-b6d9-56b39a335f40 61 fields · synced May 16, 2026
- EUDAMED 59415a99-ef4f-4a72-a90b-21233b295bb8 61 fields · synced May 16, 2026
- EUDAMED 2af2be61-a959-4f84-b90a-c7f98ba6c25c 61 fields · synced May 17, 2026
- EUDAMED 65522720-8aab-4a2b-ac9d-199916586188 61 fields · synced May 17, 2026
- EUDAMED 99fc5b65-9f52-4b7d-9d6e-473da3df6b0b 61 fields · synced May 17, 2026
- EUDAMED 611c83d9-30c8-40fe-b9ec-906f501f6d17 61 fields · synced May 17, 2026
- EUDAMED e01e45fb-0db2-41b4-904f-9c1341ac89d2 61 fields · synced May 17, 2026
- EUDAMED e2d09075-c75b-4c72-b550-8612f934eb05 61 fields · synced May 17, 2026
- EUDAMED ed4c9015-a409-4c1d-a6d8-2825b78d1fdf 61 fields · synced May 17, 2026
- EUDAMED 7034a76d-2d39-4965-b9b9-f80c30d3e71b 61 fields · synced May 17, 2026
- EUDAMED ff10607f-6f5b-46b2-ad05-8ee94815af2f 61 fields · synced May 17, 2026
- EUDAMED 1ab7cef5-70d8-4a2a-b440-6f92eebce44e 61 fields · synced May 17, 2026
- EUDAMED 6d33dfa3-4557-416a-8684-64c36206a75b 61 fields · synced May 18, 2026
- EUDAMED 34fced5d-328d-4883-b699-472d390be635 61 fields · synced May 18, 2026
- EUDAMED 0a82f472-fbf9-4b66-b92b-9642aa676e33 61 fields · synced May 18, 2026
- EUDAMED 48b90840-bd22-4209-a2eb-3d9944c4b8d3 61 fields · synced May 18, 2026
- EUDAMED dc1cb7d4-31f0-4d1a-a629-338d97501ed5 61 fields · synced May 18, 2026
- EUDAMED e669bb5f-b989-44cc-adc8-8e8fad9aea06 61 fields · synced May 18, 2026
- EUDAMED e515df7b-d561-45bc-9c51-16b423786ec6 61 fields · synced May 18, 2026
- EUDAMED 4e402599-df32-4b41-9a8a-d713ae7f8523 61 fields · synced May 18, 2026
- EUDAMED 96a0a404-b752-4db8-aa2c-4263cde6f902 61 fields · synced May 18, 2026
- EUDAMED 9775091b-0bbb-46ce-a8b7-246051b532db 61 fields · synced May 18, 2026
- EUDAMED faa92534-bcb0-426e-a362-16a62b117829 61 fields · synced May 18, 2026
- EUDAMED c2e7d6f9-66c7-408b-af42-d6a7936d20df 61 fields · synced May 18, 2026
- EUDAMED b51acf4b-5a56-4335-bd10-50bc7bf93867 61 fields · synced May 19, 2026
- EUDAMED bf292b28-2749-4de1-b384-8da750f1ed70 61 fields · synced May 19, 2026
- EUDAMED 36b513a4-19df-42e0-8f86-6c6e945d4930 61 fields · synced May 19, 2026