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Human Leukocyte Antigen B27 Nucleic Acid Detection Kit (Fluorescence PCR)

EUDAMED

Class IVD General (EU MDR)

Ref HWTS-GE011Ref P118H

by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Identity

Trade Name
Human Leukocyte Antigen B27 Nucleic Acid Detection Kit (Fluorescence PCR) EUDAMED
Device Name
Human Leukocyte Antigen B27 Nucleic Acid Detection Kit (Fluorescence PCR) EUDAMED
Human Leukocyte Antigen B27 Nucleic Acid Detection Kit (Fluorescence PCR Method) EUDAMED
Model / Reference
HWTS-GE011 EUDAMED
P118H EUDAMED

Identifiers

Primary DI / UDI-DI
D-000012807187064RE EUDAMED
06974858560174 EUDAMED
Basic UDI-DI
B-000012807187064RE EUDAMED
B-06974858560174 EUDAMED
EMDN Code
W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMED
W0106010401 HLA-TYPING EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Spain EUDAMED
Italy 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

Human Leukocyte Antigen B27 Nucleic Acid Detection Kit (Fluorescence PCR) by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. — Class IVD General — IVDD — listed…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
EUDAMED SRN
CN-MF-000012807
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (2)

  • EUDAMED c45b8bce-93ec-4768-9598-53f430eea2fd 61 fields · synced Jun 20, 2026
  • EUDAMED b2b4087d-fcd7-4a38-a9f2-088897583bf1 61 fields · synced May 16, 2026