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Blood Glucose (BG), Hematocrit (HCT) and Hemoglobin (HB) Test Strip

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref ACS051

by ForaCare Suisse AG

Identity

Trade Name
Blood Glucose (BG), Hematocrit (HCT) and Hemoglobin (HB) Test Strip EUDAMED
Device Name
Blood Glucose, Hematocrit and Hemoglobin Test Strip EUDAMED
Model / Reference
ACS051 EUDAMED

Identifiers

Primary DI / UDI-DI
07640143657865 EUDAMED
07640143658817 EUDAMED
07640143657636 EUDAMED
07640143650781 EUDAMED
Basic UDI-DI
B-07640143657865 EUDAMED
B-07640143658817 EUDAMED
B-07640143657636 EUDAMED
B-07640143650781 EUDAMED
EMDN Code
W0101060101 GLUCOSE TEST STRIPS EUDAMED

Classification

Device Class
Class IVD Annex II List B EUDAMED
Market of Registration
Germany 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

Yes

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Blood Glucose (BG), Hematocrit (HCT) and Hemoglobin (HB) Test Strip by ForaCare Suisse AG — Class IVD Annex II List B — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
ForaCare Suisse AG
EUDAMED SRN
CH-MF-000019906
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (4)

  • EUDAMED bfb6bb8a-0244-4c99-b28e-87f5801325b8 61 fields · synced Oct 6, 2026
  • EUDAMED 9894bd9d-cae8-48f5-80d6-38d10882e570 61 fields · synced May 16, 2026
  • EUDAMED e1b7d09b-fc91-4199-8b8b-c76e5b5243e9 61 fields · synced May 17, 2026
  • EUDAMED aab6ebf9-7dc3-466e-b2ec-060cbd8fc5d4 61 fields · synced May 17, 2026