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Glucocard Sm Test Strips

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref 102328Ref 47393Ref 102326Ref 47395Ref 102327

by ARKRAY Factory, Inc.

Identity

Trade Name
GLUCOCARD SM TEST STRIPS EUDAMED
Device Name
GLUCOCARD SM TEST STRIPS EUDAMED
Model / Reference
102328 EUDAMED
47393 EUDAMED
102326 EUDAMED
47395 EUDAMED
102327 EUDAMED

Identifiers

Primary DI / UDI-DI
D-102328LP EUDAMED
D-47393HT EUDAMED
D-102326LK EUDAMED
D-47395HX EUDAMED
D-102327LM EUDAMED
Basic UDI-DI
B-102328LP EUDAMED
B-47393HT EUDAMED
B-102326LK EUDAMED
B-47395HX EUDAMED
B-102327LM EUDAMED
EMDN Code
W0101060101 GLUCOSE TEST STRIPS EUDAMED

Classification

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

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Glucocard Sm 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 (5)

  • EUDAMED 637fe8f2-4da8-413b-9fc6-905dfbce0c20 61 fields · synced Jul 30, 2026
  • EUDAMED fbc26b79-e0a4-415e-80f4-982403013bfb 61 fields · synced May 17, 2026
  • EUDAMED b24e8f89-47d4-4ee2-977a-980c4271c1fc 61 fields · synced May 18, 2026
  • EUDAMED 8ad2ae00-d9e6-4246-bb08-e75c3aacfdba 61 fields · synced May 19, 2026
  • EUDAMED f62b1f4b-e4e8-408f-ad88-2e20f1452251 61 fields · synced May 19, 2026