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Automatic Chemiluminescence lmmunoanalyzer
EUDAMEDClass A (EU MDR)
Ref AI 2600, AI 2610, AI 2620, AI 2660, AI 2680
Identity
- Trade Name
- Automatic Chemiluminescence lmmunoanalyzer EUDAMED
- Device Name
- Automatic Chemiluminescence lmmunoanalyzer EUDAMED
- Model / Reference
- AI 2600, AI 2610, AI 2620, AI 2660, AI 2680 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978151200096 EUDAMED
- Basic UDI-DI
- 697815120CLIAAI2600Q3 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
- Netherlands 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
Automatic Chemiluminescence lmmunoanalyzer by Hangzhou Aichek Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697815120CLIAAI2600Q3 | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 0540c31f-f8f7-41c2-becc-1ae65c749b4d-1 61 fields · synced Oct 6, 2026
- EUDAMED 0540c31f-f8f7-41c2-becc-1ae65c749b4d-2 61 fields · synced Jul 9, 2026