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Calcium (Ca) Assay Kit (Arsenazo III Method)
EUDAMEDClass IVD General (EU MDR)
Ref 153H20TSCRef 153H200TSC
Identity
- Trade Name
- Calcium (Ca) Assay Kit (Arsenazo III Method) EUDAMED
- Device Name
- Calcium (Ca) Assay Kit (Arsenazo III Method) EUDAMED
- Model / Reference
- 153H20TSC EUDAMED153H200TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-153H20TSC3X EUDAMEDD-153H200TSCKQ EUDAMED
- Basic UDI-DI
- B-153H20TSC3X EUDAMEDB-153H200TSCKQ EUDAMED
- EMDN Code
- W01010303 CALCIUM 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
Calcium (Ca) Assay Kit (Arsenazo III Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-153H20TSC3X | 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 03d565c4-72cb-4d4c-af94-04001ec85b09 61 fields · synced Oct 6, 2026
- EUDAMED e83f702f-1714-48f4-afb2-be0d76181b97 61 fields · synced May 18, 2026