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Aucheer iSort 300 Dry fluorescence immunoassay analyzer
EUDAMEDClass A (EU MDR)
Ref M0300
Identity
- Trade Name
- Aucheer iSort 300 Dry fluorescence immunoassay analyzer EUDAMED
- Device Name
- Aucheer iSort 300 Dry fluorescence immunoassay analyzer EUDAMED
- Model / Reference
- M0300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974546543397 EUDAMED
- Basic UDI-DI
- 0697454654M0300YN EUDAMED
- Direct Marketing DI
- 06974546543397 EUDAMED
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS 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 iSort 300 Dry fluorescence 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 | 0697454654M0300YN | 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 eace40fe-e697-406c-82e3-98eb5581b916 61 fields · synced Jun 19, 2026