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GLUCOCARD S Test Strips

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref 101471Ref 109326Ref 109333Ref 108494Ref 101542Ref 101075Ref 108497Ref 108986Ref 101472Ref 108987Ref 109328Ref 101413Ref 109327Ref 101541Ref 101726Ref 109331Ref 101074Ref 109216Ref 109330

by ARKRAY Factory, Inc.

Identity

Trade Name
GLUCOCARD S Test Strips EUDAMED
Device Name
GLUCOCARD S Test Strips EUDAMED
Model / Reference
101471 EUDAMED
109326 EUDAMED
109333 EUDAMED
108494 EUDAMED
101542 EUDAMED
101075 EUDAMED
108497 EUDAMED
108986 EUDAMED
101472 EUDAMED
108987 EUDAMED
109328 EUDAMED
101413 EUDAMED
109327 EUDAMED
101541 EUDAMED
101726 EUDAMED
109331 EUDAMED
101074 EUDAMED
109216 EUDAMED
109330 EUDAMED

Identifiers

Primary DI / UDI-DI
D-101471LN EUDAMED
D-109326N4 EUDAMED
D-109333MZ EUDAMED
D-108494NK EUDAMED
D-101542LL EUDAMED
D-101075LA EUDAMED
D-108497NR EUDAMED
D-108986PD EUDAMED
D-101472LQ EUDAMED
D-108987PF EUDAMED
D-109328N8 EUDAMED
D-101413L8 EUDAMED
D-109327N6 EUDAMED
D-101541LJ EUDAMED
D-101726LY EUDAMED
D-109331MV EUDAMED
D-101074L8 EUDAMED
D-109216MU EUDAMED
D-109330MT EUDAMED
Basic UDI-DI
B-101471LN EUDAMED
B-109326N4 EUDAMED
B-109333MZ EUDAMED
B-108494NK EUDAMED
B-101542LL EUDAMED
B-101075LA EUDAMED
B-108497NR EUDAMED
B-108986PD EUDAMED
B-101472LQ EUDAMED
B-108987PF EUDAMED
B-109328N8 EUDAMED
B-101413L8 EUDAMED
B-109327N6 EUDAMED
B-101541LJ EUDAMED
B-101726LY EUDAMED
B-109331MV EUDAMED
B-101074L8 EUDAMED
B-109216MU EUDAMED
B-109330MT EUDAMED
EMDN Code
W0101060101 GLUCOSE TEST STRIPS EUDAMED

Classification

Device Class
Class IVD Annex II List B EUDAMED
Market of Registration
Croatia EUDAMED
Ireland EUDAMED
Lithuania EUDAMED
France EUDAMED
Romania EUDAMED
Czechia EUDAMED
Spain 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

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

GLUCOCARD S Test Strips by ARKRAY Factory, Inc. — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
ARKRAY Factory, Inc.
EUDAMED SRN
JP-MF-000003008
Authorised Representative
ARKRAY Europe, B.V. NL-AR-000002056

Sources (19)

  • EUDAMED d7b1d120-20a9-41b9-bb99-0715ddb14822 61 fields · synced Sep 18, 2026
  • EUDAMED 6c852d4e-f48f-4567-8c82-2f4a035c4c29 61 fields · synced May 16, 2026
  • EUDAMED 579ac58e-5501-4f69-b83f-95655a75e0ae 61 fields · synced May 16, 2026
  • EUDAMED 47a262d6-641d-49c9-a724-bd69af91f1a5 61 fields · synced May 16, 2026
  • EUDAMED 4de0bfe2-c609-45cb-a83a-d90aa5cb2ac8 61 fields · synced May 17, 2026
  • EUDAMED 2c289c8b-8e45-44a4-a562-2cfce8c78d76 61 fields · synced May 17, 2026
  • EUDAMED f401a894-206f-46ba-8c07-d6985c00f595 61 fields · synced May 17, 2026
  • EUDAMED e3199aeb-739a-4fea-92d1-2f7bbdc0bded 61 fields · synced May 17, 2026
  • EUDAMED d371e2e8-91b5-4971-9d5c-3b80704a13cc 61 fields · synced May 17, 2026
  • EUDAMED 8a3e9680-0133-4f5f-b0c9-b09d4c9f2bc5 61 fields · synced May 17, 2026
  • EUDAMED a1ba1dae-5ab2-4314-a96e-da4bfc62df3d 61 fields · synced May 17, 2026
  • EUDAMED f1d24d4f-fe93-4a04-a367-05018bc067cc 61 fields · synced May 17, 2026
  • EUDAMED ff91fc60-eafa-4950-add6-b24a1382cd3f 61 fields · synced May 18, 2026
  • EUDAMED dc85442f-9db4-40f6-b164-c368e6ab39ca 61 fields · synced May 18, 2026
  • EUDAMED 98e2eb31-d1e4-41db-ae19-626e7918dcdc 61 fields · synced May 18, 2026
  • EUDAMED cdd6660c-9d09-4f52-815d-eecfabffbc84 61 fields · synced May 18, 2026
  • EUDAMED 34a6135d-12cb-4406-a676-4e9850d9a28f 61 fields · synced May 19, 2026
  • EUDAMED 35df6a1a-cf8f-4e3c-991b-a91e9ca32017 61 fields · synced May 19, 2026
  • EUDAMED a7a34b49-0d25-4532-b654-626ee1b4f50b 61 fields · synced May 19, 2026