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Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric)

EUDAMED

Class IVD General (EU MDR)

Ref R1:30mL×1 R2:10mL×1（715）Ref R1:30mL×2 R2:20mL×1（792）Ref R1:30mL×1 R2:10mL×1（713）Ref R1:30mL×2 R2:20mL×1（791）Ref R1:60mL×1 R2:20mL×1（708）Ref R1:30mL×2 R2:20mL×1（709）Ref Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) Model R1:60mL×1 R2:20mL×1（706）Ref R1:60mL×1 R2:20mL×1（701）

by Biobase Biodustry(Shandong) Co., Ltd.

Identity

Trade Name
Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
Device Name
Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
Model / Reference
R1:30mL×1 R2:10mL×1（715） EUDAMED
R1:30mL×2 R2:20mL×1（792） EUDAMED
R1:30mL×1 R2:10mL×1（713） EUDAMED
R1:30mL×2 R2:20mL×1（791） EUDAMED
R1:60mL×1 R2:20mL×1（708） EUDAMED
R1:30mL×2 R2:20mL×1（709） EUDAMED
R1:60mL×1 R2:20mL×1（706） EUDAMED
Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) EUDAMED
R1:60mL×1 R2:20mL×1（701） EUDAMED

Identifiers

Primary DI / UDI-DI
06971674869481 EUDAMED
06971674869450 EUDAMED
06971674869474 EUDAMED
06971674869443 EUDAMED
06971674869436 EUDAMED
06971674869382 EUDAMED
06971674869429 EUDAMED
06971674869375 EUDAMED
Basic UDI-DI
B-06971674869481 EUDAMED
B-06971674869450 EUDAMED
B-06971674869474 EUDAMED
B-06971674869443 EUDAMED
B-06971674869436 EUDAMED
B-06971674869382 EUDAMED
B-06971674869429 EUDAMED
B-06971674869375 EUDAMED
EMDN Code
W01010214 GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany 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

Glycohemoglobin A1c (HbA1c) Test Kit (Latex Enhanced Immunoturbidimetric) by Biobase Biodustry(Shandong) Co., Ltd. — Class IVD General — IVDD — listed in…

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
Biobase Biodustry(Shandong) Co., Ltd.
EUDAMED SRN
CN-MF-000025015
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (8)

  • EUDAMED c16830ac-a53d-460a-a3e1-58e851331daf 61 fields · synced Oct 6, 2026
  • EUDAMED c485c364-1ce7-4091-89f3-1af680152763 61 fields · synced May 16, 2026
  • EUDAMED cce5c13a-286c-4487-a1da-0a4ba37a95d4 61 fields · synced May 17, 2026
  • EUDAMED d5ea697c-ad7d-42eb-a98c-3464b09b38e0 61 fields · synced May 17, 2026
  • EUDAMED 2d3a659e-d011-4db9-b167-5b2ba892d88c 61 fields · synced May 18, 2026
  • EUDAMED 7eae2e99-9be7-4299-8c94-999667a43d18 61 fields · synced May 18, 2026
  • EUDAMED a0a07fc8-cbfb-4c6f-a17c-dc98da6013e9 61 fields · synced May 18, 2026
  • EUDAMED 64fdf8ee-c1d6-4215-9022-2fa12e3baeb6 61 fields · synced May 19, 2026