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Creatinine (CRE) Assay Kit (Enzymatic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 74H40TRef 74H240TSCRef 74H40TSC
Identity
- Trade Name
- Creatinine (CRE) Assay Kit (Enzymatic Method) EUDAMED
- Device Name
- Creatinine (CRE) Assay Kit (Enzymatic Method) EUDAMED
- Model / Reference
- 74H40T EUDAMED74H240TSC EUDAMED74H40TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-74H40TWR EUDAMEDD-74H240TSCAF EUDAMEDD-74H40TSCU7 EUDAMED
- Basic UDI-DI
- B-74H40TWR EUDAMEDB-74H240TSCAF EUDAMEDB-74H40TSCU7 EUDAMED
- EMDN Code
- W01010207 CREATININE 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
Creatinine (CRE) Assay Kit (Enzymatic 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-74H40TWR | 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 (3)
- EUDAMED 3dbd6c9e-8b1b-4a5c-9ea1-a512e416b415 61 fields · synced Oct 6, 2026
- EUDAMED c76ed239-08c8-4ba7-9c26-477fac161a4f 61 fields · synced May 17, 2026
- EUDAMED 125fb978-18eb-4add-a879-76636f3b9bf2 61 fields · synced May 19, 2026