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Apolipoprotein B (Apo B) Reagent Kit (Immunoturbidimetric Assay)
EUDAMEDClass B (EU MDR)
Ref /
Identity
- Device Name
- Apolipoprotein B (Apo B) Reagent Kit (Immunoturbidimetric Assay) EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740733496 EUDAMED06935740733502 EUDAMED06935740733519 EUDAMED06935740740838 EUDAMED06935740739429 EUDAMED
- Basic UDI-DI
- 69357407ICAS000038B7 EUDAMED
- EMDN Code
- W0102010403 APOLIPOPROTEIN B EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Apolipoprotein B (Apo B) Reagent Kit (Immunoturbidimetric Assay) by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69357407ICAS000038B7 | Class B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (5)
- EUDAMED e71735b2-3f8d-439e-ac64-a6efb0101143 61 fields · synced Oct 6, 2026
- EUDAMED 4c608205-abbe-4e69-8ea9-15406c94dca8 61 fields · synced May 17, 2026
- EUDAMED f2fed55e-ead9-4e07-964e-3ab7424be5d4 61 fields · synced May 18, 2026
- EUDAMED d52af1e5-172a-4e1e-bc8a-5d16e16de894 61 fields · synced May 18, 2026
- EUDAMED 4a67c0e0-737a-46e7-a804-30b2f055afa5 61 fields · synced May 19, 2026