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Blood Urea Nitrogen (BUN) Assay Kit (Enzymatic Kinetic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 73H50TSC
Identity
- Trade Name
- Blood Urea Nitrogen (BUN) Assay Kit (Enzymatic Kinetic Method) EUDAMED
- Device Name
- Blood Urea Nitrogen (BUN) Assay Kit (Enzymatic Kinetic Method) EUDAMED
- Model / Reference
- 73H50TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-73H50TSCTZ EUDAMED
- Basic UDI-DI
- B-73H50TSCTZ EUDAMED
- EMDN Code
- W01010204 UREA/BLOOD UREA NITROGEN 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
Blood Urea Nitrogen (BUN) Assay Kit (Enzymatic Kinetic 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-73H50TSCTZ | 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 (1)
- EUDAMED 83c9ad1e-2deb-45eb-9d35-0196bdc94437 61 fields · synced Jun 19, 2026