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Automatic Chemiluminescence Immunoassay Analyzer
EUDAMEDClass A (EU MDR)
Ref ACIR-100Ref ACIR-200
Identity
- Trade Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Device Name
- Automatic Chemiluminescence Immunoassay Analyzer EUDAMED
- Model / Reference
- ACIR-100 EUDAMEDACIR-200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936983107440 EUDAMED06936983110389 EUDAMED
- Basic UDI-DI
- 6970277510002VYT EUDAMED6970277510005QYS EUDAMED
- Direct Marketing DI
- 06936983107440 EUDAMED06936983110389 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Automatic Chemiluminescence Immunoassay Analyzer by Hangzhou Alltest Biotech.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 | 6970277510002VYT | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Alltest Biotech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010710
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 918bcb1a-2694-4ff8-a87c-05fec0628c6f 61 fields · synced Oct 6, 2026
- EUDAMED bd300c45-10c6-48d2-9e1d-37ce475a2677 61 fields · synced May 18, 2026