Aia-Pack Bmg Calibrator Set
EUDAMEDFDA UDIClass IVD General (EU MDR)
Identity
- Trade Name
- AIA-PACK BMG Calibrator Set FDA UDI
- Generic Name
- Beta-2-microglobulin IVD, calibrator FDA UDI
- Device Name
- AIA-PACK BMG CALIBRATOR SET EUDAMED
- Model / Reference
- 0020359 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211186 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189211186 EUDAMED
- FDA Product Code
- JZG FDA UDI
- EMDN Code
- W0102039002 BETA2-MICROGLOBULIN EUDAMED
- GMDN Term
- Beta-2-microglobulin IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5630 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Beta-2-microglobulin IVD, reagent
Aia-Pack Bmg Calibrator Set by Tosoh Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — 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
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- 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 (2 countries)
Regulatory Authorizations
CE/IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04560189211186 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED ae8751b2-cc7f-446f-b256-408c75018d5b 61 fields · synced Jul 11, 2026
- FDA UDI 6ecee664-0110-4728-aaec-bcad45e0ebf8 34 fields · synced May 30, 2026