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Migele Gel Electrophoresis Unit (IVD)
EUDAMEDFDA UDIClass A (EU MDR)
Ref 2118-0010
by Wallac Oy
Identity
- Trade Name
- Migele Gel Electrophoresis Unit (IVD) EUDAMEDMigele Gel Electrophoresis Unit FDA UDI
- Generic Name
- Electrophoresis analyser IVD FDA UDI
- Device Name
- Migele Gel Electrophoresis Unit (IVD) EUDAMEDMigele™ Gel Electrophoresis Unit (GEU) is intended for professional use together with power supply, water bath and isoelectric focusing (IEF) gels. GEU is used for the isoelectric point-based separation of sample compounds, e.g. hemoglobin variants found in blood samples, by applying a given amount of electrical current to the immobilized pH-gradient containing agarose. FDA UDI
- Model / Reference
- 2118-0010 EUDAMEDFDA UDI
- Description
- Migele™ Gel Electrophoresis Unit (GEU) is intended for professional use together with power supply, water bath and isoelectric focusing (IEF) gels. GEU is used for the isoelectric point-based separation of sample compounds, e.g. hemoglobin variants found in blood samples, by applying a given amount of electrical current to the immobilized pH-gradient containing agarose. FDA UDI
Identifiers
- Catalog Number
- 2118-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147368907 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147Migele_3D EUDAMED
- FDA Product Code
- JJN FDA UDI
- EMDN Code
- W020105019001 ELECTROPHORETIC GEL PROCESSORS EUDAMED
- GMDN Term
- Electrophoresis analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2485 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Migele Gel Electrophoresis Unit (IVD) by Wallac Oy — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147Migele_3D | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED 5731d6ca-9931-4a48-9e42-00c4d26025db 61 fields · synced Jul 11, 2026
- FDA UDI 0b42a432-a889-4ff1-9b4a-630a762d455c 34 fields · synced May 29, 2026