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LiCA LS Solution
EUDAMEDClass A (EU MDR)
Ref 12010000841Model 2 × 105 mL; 4 × 45 mL; 6 × 18 mL
Identity
- Trade Name
- LiCA LS Solution EUDAMED
- Device Name
- LiCA LS Solution EUDAMED
- Model / Reference
- 2 × 105 mL; 4 × 45 mL; 6 × 18 mL EUDAMED12010000841 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978638651977 EUDAMED
- Basic UDI-DI
- 6973864380101EB EUDAMED
- EMDN Code
- W0599 IVD GENERAL USE CONSUMABLE DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
LiCA LS Solution 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 | 6973864380101EB | 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 (1)
- EUDAMED 6243a6fc-f3b3-4609-9c6c-1cd115610183 61 fields · synced Sep 18, 2026