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Immunoglobulin E Kit (Latex-Enhanced Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ466YModel 60ml(R1:1×40mL+R2:1×20mL)
Identity
- Trade Name
- Immunoglobulin E Kit (Latex-Enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Immunoglobulin E Kit (Latex-Enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 60ml(R1:1×40mL+R2:1×20mL) EUDAMEDMJ466Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750881 EUDAMED
- Basic UDI-DI
- B-06936595750881 EUDAMED
- EMDN Code
- W01020201 IMMUNOGLOBULIN E - TOTAL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Immunoglobulin E Kit (Latex-Enhanced Immunoturbidimetric Method) by Medicalsystem Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-06936595750881 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED de97ebe4-d204-45e3-a975-b7d68e2dd351 61 fields · synced Jun 18, 2026