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Glycated Hemoglobin (HbA1c) Assay Kit (Latex-enhanced Immunoturbidimetric Metho…
EUDAMEDClass IVD General (EU MDR)
Ref 86H40TSCRef 86H160TSC
Identity
- Trade Name
- Glycated Hemoglobin (HbA1c) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- Glycated Hemoglobin (HbA1c) Assay Kit (Latex-enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 86H40TSC EUDAMED86H160TSC EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-86H40TSCVU EUDAMEDD-86H160TSCCM EUDAMED
- Basic UDI-DI
- B-86H40TSCVU EUDAMEDB-86H160TSCCM EUDAMED
- EMDN Code
- W0102160102 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC 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
Glycated Hemoglobin (HbA1c) Assay Kit (Latex-enhanced Immunoturbidimetric Metho… by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in…
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-86H40TSCVU | 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 9b1707bf-6dd9-40e2-b775-8502ed4d746e 61 fields · synced Oct 7, 2026
- EUDAMED 327e8d80-37ac-4f88-a9f8-b49205f4e199 61 fields · synced May 18, 2026