← Back to catalogue
β2-Microglobulin（β2-MG）
EUDAMEDClass IVD General (EU MDR)
Ref ECH0503055Ref ECH0101055Ref ECH0502055Ref ECH0103055Ref ECH0109055
Identity
- Device Name
- β2-Microglobulin（β2-MG） EUDAMED
- Model / Reference
- ECH0503055 EUDAMEDECH0101055 EUDAMEDECH0502055 EUDAMEDECH0103055 EUDAMEDECH0109055 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ECH05030556W EUDAMEDD-ECH01010554U EUDAMEDD-ECH05020556P EUDAMEDD-ECH01030555A EUDAMEDD-ECH01090556L EUDAMED
- Basic UDI-DI
- B-ECH05030556W EUDAMEDB-ECH01010554U EUDAMEDB-ECH05020556P EUDAMEDB-ECH01030555A EUDAMEDB-ECH01090556L EUDAMED
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
β2-Microglobulin（β2-MG） by Maccura Biotechnology Co., Ltd. — 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
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- Beta2-microglobulin urine — Diagam S.A. · IVD General
- Beta2-microglobulin — Diagam S.A. · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- BETA2-Microglobulin (BETA2-MG) Test — Beijing Jinwofu Bioengineering Technology Co., Ltd. · 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-ECH05030556W | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED 2f1209eb-c49b-4aac-88de-246f886ce8a5 61 fields · synced Aug 1, 2026
- EUDAMED e41506f1-af6d-4994-b1f3-d653d67bd0a7 61 fields · synced May 16, 2026
- EUDAMED e4989ce1-668b-4886-966f-351a0029ac25 61 fields · synced May 17, 2026
- EUDAMED 0acb5c1f-51b6-413e-a3f6-0c8fb5a392e9 61 fields · synced May 17, 2026
- EUDAMED 5421ded5-24e4-436b-8bca-929d8a064f81 61 fields · synced May 18, 2026