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Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref C1800Model iMAGIN 1800
Identity
- Trade Name
- Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- iMAGIN 1800 EUDAMEDC1800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974546541256 EUDAMED
- Basic UDI-DI
- 0697454654C1800W8 EUDAMED
- Direct Marketing DI
- 06974546541256 EUDAMED
- EMDN Code
- W0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer by Ningbo Aucheer Biotechnology Co., Ltd. — Class A — 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 | 0697454654C1800W8 | Class A | Active |
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Manufacturer
- Manufacturer
- Ningbo Aucheer Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000038081
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED fe2b25ef-d9d6-47c2-aedf-ec267a88fa6c 61 fields · synced Jul 9, 2026