← Back to catalogue

Test Cartridge

EUDAMED

Class IVD General (EU MDR)

Ref BG3Ref iBG3Ref BG4Ref BG10Ref iBG8-OXI

by Edan Instruments, Inc.

Identity

Trade Name
Test Cartridge EUDAMED
Device Name
Test Cartridge EUDAMED
Model / Reference
BG3 EUDAMED
iBG3 EUDAMED
BG4 EUDAMED
BG10 EUDAMED
iBG8-OXI EUDAMED

Identifiers

Primary DI / UDI-DI
06944413825659 EUDAMED
06944413815520 EUDAMED
06944413802995 EUDAMED
06944413832541 EUDAMED
06944413815315 EUDAMED
Basic UDI-DI
B-06944413825659 EUDAMED
B-06944413815520 EUDAMED
B-06944413802995 EUDAMED
B-06944413832541 EUDAMED
B-06944413815315 EUDAMED
EMDN Code
W0101060605 BG &/OR ISE &/OR METABOLITES - ELECTRODES (BG) 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

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Test Cartridge by Edan Instruments, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Edan Instruments, Inc.
EUDAMED SRN
CN-MF-000009957
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (5)

  • EUDAMED e3ad2cc8-176b-4666-96d9-7c7f11eb35f5 61 fields · synced Aug 1, 2026
  • EUDAMED 7bb1fdf9-dca6-4848-ae94-125226be3c17 61 fields · synced May 16, 2026
  • EUDAMED c70c76ca-9e36-4d5f-970c-4a5098cdf50f 61 fields · synced May 16, 2026
  • EUDAMED 95e3f0e4-f5ed-4502-9170-3f6d6beb4282 61 fields · synced May 16, 2026
  • EUDAMED 43016ffb-26bd-4d7d-815d-a9bcdf12a0f3 61 fields · synced May 19, 2026