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Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method)

EUDAMED

Class IVD General (EU MDR)

Ref 58H40TSCRef 58H240TRef 58H240TSCRef 58H40T

by Yhlo Biotech (nanjing) Co., Ltd.

Identity

Trade Name
Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method) EUDAMED
Device Name
Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling Method) EUDAMED
Model / Reference
58H40TSC EUDAMED
58H240T EUDAMED
58H240TSC EUDAMED
58H40T EUDAMED

Identifiers

Primary DI / UDI-DI
D-58H40TSCV5 EUDAMED
D-58H240TAR EUDAMED
D-58H240TSCBD EUDAMED
D-58H40TXB EUDAMED
Basic UDI-DI
B-58H40TSCV5 EUDAMED
B-58H240TAR EUDAMED
B-58H240TSCBD EUDAMED
B-58H40TXB EUDAMED
EMDN Code
W01010202 BILE ACIDS 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

Total Bile Acids (TBA) Assay Kit (Enzymatic Cycling 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

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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 (4)

  • EUDAMED 625cfabf-a1aa-427d-a4d2-a1334f20cf59 61 fields · synced Oct 6, 2026
  • EUDAMED ab2fbd87-202a-4277-a6a5-ff72b1399f2d 61 fields · synced May 16, 2026
  • EUDAMED 58728551-8479-42fd-8182-4325f4884b35 61 fields · synced May 17, 2026
  • EUDAMED 3de84617-7007-4d97-b42a-01ac5a0c4e11 61 fields · synced May 18, 2026