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Fecal Occult Blood (FOB) Test Kit (LIA)

EUDAMED

Class B (EU MDR)

Ref BQX2Model Hitachi 7020, 7180, Beckman AU680,OC-Sensor IO

by Hunan Hehao Medical Technology Co., Ltd.

Identity

Trade Name
Fecal Occult Blood (FOB) Test Kit (LIA) EUDAMED
Device Name
Fecal Occult Blood (FOB) Test Kit (LIA) EUDAMED
Model / Reference
Hitachi 7020, 7180, Beckman AU680,OC-Sensor IO EUDAMED
BQX2 EUDAMED

Identifiers

Primary DI / UDI-DI
06975867980014 EUDAMED
06975867980038 EUDAMED
Basic UDI-DI
695786798BQX01XK EUDAMED
B-06975867980014 EUDAMED
B-06975867980038 EUDAMED
Direct Marketing DI
06975867980014 EUDAMED
EMDN Code
W0103010201 HAEMOGLOBIN DETERMINATIONS (TOTAL HB) EUDAMED

Classification

Device Class
Class B EUDAMED
Class IVD General EUDAMED
Market of Registration
Ireland EUDAMED
Netherlands 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

New Device

No

EUDAMED

Fecal Occult Blood (FOB) Test Kit (LIA) by Hunan Hehao Medical Technology Co., Ltd. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hunan Hehao Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000029298
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (3)

  • EUDAMED a9b19a63-f5d0-4244-93cc-0902944e7437 61 fields · synced Oct 6, 2026
  • EUDAMED 6452f800-b69d-44fb-9c70-7cd212885b4b 61 fields · synced May 16, 2026
  • EUDAMED 92fc044d-3c84-4f16-8378-2ed07227a8ee 61 fields · synced May 19, 2026