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LiCA Toxo lgG
EUDAMEDClass C (EU MDR)
Ref 05010828332Model 2 × 50 Tests; 2 × 50 Tests; 2 × 100 Tests; 4 × 100 Tests
Identity
- Trade Name
- LiCA Toxo lgG EUDAMED
- Device Name
- LiCA Toxo IgG EUDAMED
- Model / Reference
- 2 × 50 Tests; 2 × 50 Tests; 2 × 100 Tests; 4 × 100 Tests EUDAMED05010828332 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973864382664 EUDAMED
- Basic UDI-DI
- 6973864380046EU EUDAMED
- EMDN Code
- W0105050102 TOXOPLASMA ANTIBODY IGG EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
LiCA Toxo lgG by Chemclin Diagnostics Co., Ltd. — Class C — 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 | 6973864380046EU | Class C | 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 4e69deea-1ce8-48b3-b1a3-0f5753cd6ec1 61 fields · synced Jul 9, 2026