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LiCA Homogeneous Chemiluminescence System (LiCA System)
EUDAMEDClass A (EU MDR)
Ref 04090115300Model LiCA PT 1000Ref 04090113000Model LiCA Smart
Identity
- Device Name
- LiCA Homogeneous Chemiluminescence System (LiCA System) EUDAMED
- Model / Reference
- LiCA PT 1000 EUDAMED04090115300 EUDAMEDLiCA Smart EUDAMED04090113000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864382923 EUDAMED06973864380523 EUDAMED
- Basic UDI-DI
- 6973864380106EM EUDAMED6973864380104EH EUDAMED
- Direct Marketing DI
- 06973864382923 EUDAMED06973864380523 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMEDW0201020102 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Czechia 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
LiCA Homogeneous Chemiluminescence System (LiCA System) by Chemclin Diagnostics 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 | 6973864380106EM | Class A | Active |
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Manufacturer
- Manufacturer
- Chemclin Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000009729
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED ef296bae-45de-4df0-ba96-55632ad45e48 61 fields · synced Jul 16, 2026
- EUDAMED 96a46c35-999b-4567-89f0-71210192a638 61 fields · synced May 19, 2026