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Lithium (Li) Assay Kit (Porphyrin-like Colorimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 140H200TSCRef 140H60TSC
Identity
- Trade Name
- Lithium (Li) Assay Kit (Porphyrin-like Colorimetric Method) EUDAMED
- Device Name
- Lithium (Li) Assay Kit (Porphyrin-like Colorimetric Method) EUDAMED
- Model / Reference
- 140H200TSC EUDAMED140H60TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-140H200TSCH8 EUDAMEDD-140H60TSC35 EUDAMED
- Basic UDI-DI
- B-140H200TSCH8 EUDAMEDB-140H60TSC35 EUDAMED
- EMDN Code
- W01010305 LITHIUM EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Lithium (Li) Assay Kit (Porphyrin-like Colorimetric Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-140H200TSCH8 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED a1c0efc6-eb16-439d-addc-3a305fd26136 61 fields · synced Jul 23, 2026
- EUDAMED 2de22319-33a3-4dcb-93f9-0764fa1b1bc8 61 fields · synced May 19, 2026