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Test Cartridge

EUDAMED

Class IVD General (EU MDR)

Ref BG8Ref iBG3Ref iBC4Ref MicroSample-BG8Ref BG10Ref MicroSample-BC4Ref BG3Ref MicroSample-BG3Ref iBG8-OXIRef MicroSample-BG10Ref BG4Ref iBG8Ref iBG4

by Edan Instruments, Inc.

Identity

Trade Name
Test Cartridge EUDAMED
Device Name
Test Cartridge EUDAMED
Model / Reference
BG8 EUDAMED
iBG3 EUDAMED
iBC4 EUDAMED
MicroSample-BG8 EUDAMED
BG10 EUDAMED
MicroSample-BC4 EUDAMED
BG3 EUDAMED
MicroSample-BG3 EUDAMED
iBG8-OXI EUDAMED
MicroSample-BG10 EUDAMED
BG4 EUDAMED
iBG8 EUDAMED
iBG4 EUDAMED

Identifiers

Primary DI / UDI-DI
06944413802865 EUDAMED
06944413815506 EUDAMED
06944413815452 EUDAMED
06944413832978 EUDAMED
06944413832527 EUDAMED
06944413815438 EUDAMED
06944413825765 EUDAMED
06944413825642 EUDAMED
06944413809772 EUDAMED
06944413825802 EUDAMED
06944413809840 EUDAMED
06944413832916 EUDAMED
06944413832565 EUDAMED
06944413832145 EUDAMED
06944413815346 EUDAMED
06944413833364 EUDAMED
06944413803077 EUDAMED
06944413825680 EUDAMED
06944413825741 EUDAMED
06944413832077 EUDAMED
06944413815360 EUDAMED
06944413832985 EUDAMED
06944413815384 EUDAMED
06944413832084 EUDAMED
06944413832558 EUDAMED
06944413833319 EUDAMED
06944413832909 EUDAMED
06944413815414 EUDAMED
06944413832510 EUDAMED
06944413815513 EUDAMED
06944413815322 EUDAMED
06944413815445 EUDAMED
06944413822207 EUDAMED
06944413810013 EUDAMED
06944413815407 EUDAMED
06944413825796 EUDAMED
06944413832480 EUDAMED
06944413802209 EUDAMED
06944413832503 EUDAMED
06944413832138 EUDAMED
Basic UDI-DI
B-06944413802865 EUDAMED
B-06944413815506 EUDAMED
B-06944413815452 EUDAMED
B-06944413832978 EUDAMED
B-06944413832527 EUDAMED
B-06944413815438 EUDAMED
B-06944413825765 EUDAMED
B-06944413825642 EUDAMED
B-06944413809772 EUDAMED
B-06944413825802 EUDAMED
B-06944413809840 EUDAMED
B-06944413832916 EUDAMED
B-06944413832565 EUDAMED
B-06944413832145 EUDAMED
B-06944413815346 EUDAMED
B-06944413833364 EUDAMED
B-06944413803077 EUDAMED
B-06944413825680 EUDAMED
B-06944413825741 EUDAMED
B-06944413832077 EUDAMED
B-06944413815360 EUDAMED
B-06944413832985 EUDAMED
B-06944413815384 EUDAMED
B-06944413832084 EUDAMED
B-06944413832558 EUDAMED
B-06944413833319 EUDAMED
B-06944413832909 EUDAMED
B-06944413815414 EUDAMED
B-06944413832510 EUDAMED
B-06944413815513 EUDAMED
B-06944413815322 EUDAMED
B-06944413815445 EUDAMED
B-06944413822207 EUDAMED
B-06944413810013 EUDAMED
B-06944413815407 EUDAMED
B-06944413825796 EUDAMED
B-06944413832480 EUDAMED
B-06944413802209 EUDAMED
B-06944413832503 EUDAMED
B-06944413832138 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

EUDAMEDEUDAMED

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 (40)

  • EUDAMED 83c066cd-303e-4a7a-ac4f-9f2055a83f72 61 fields · synced Sep 18, 2026
  • EUDAMED 0f13cfae-44ef-4866-bd78-154427f1165c 61 fields · synced May 11, 2026
  • EUDAMED 9f5ad469-d324-42c2-b9b8-02b8e2f560be 61 fields · synced May 16, 2026
  • EUDAMED feb579b1-7c5d-4d1f-acf9-ab70d7326b82 61 fields · synced May 16, 2026
  • EUDAMED 80388cb2-8a79-4a75-acab-746b86518bdd 61 fields · synced May 16, 2026
  • EUDAMED 9de23ad3-bc43-41ba-ba51-1620d3584c40 61 fields · synced May 16, 2026
  • EUDAMED d1ebe2fc-dcce-4133-bafe-4dc19bda08b2 61 fields · synced May 17, 2026
  • EUDAMED 90e8c666-0926-4d39-b50b-9042d7078e8f 61 fields · synced May 17, 2026
  • EUDAMED 878d3acd-f341-437d-9934-fc29ea578012 61 fields · synced May 17, 2026
  • EUDAMED 656d06b9-c7c4-49cc-83af-8efeb497c871 61 fields · synced May 17, 2026
  • EUDAMED 7310ebdb-d855-4c3b-828a-3d2c4deffbaf 61 fields · synced May 17, 2026
  • EUDAMED 0318eacb-e54a-491a-8df8-5d815bd490ea 61 fields · synced May 17, 2026
  • EUDAMED 72fce0e3-8865-49af-8db8-63d32b5172c1 61 fields · synced May 17, 2026
  • EUDAMED b243d541-d5e5-4f74-aefd-da52a6b54005 61 fields · synced May 17, 2026
  • EUDAMED fdeedbca-9577-42dd-b497-8359d9a393ca 61 fields · synced May 17, 2026
  • EUDAMED 58159e64-cd93-4664-82d4-96b737159fe2 61 fields · synced May 17, 2026
  • EUDAMED 0237b9bd-082e-484a-9661-d6975a70bdf8 61 fields · synced May 17, 2026
  • EUDAMED 485cc43f-5c8f-4701-87ba-68a244a2d6f4 61 fields · synced May 17, 2026
  • EUDAMED e4be51ca-09d2-4a27-a47d-6ab03407560b 61 fields · synced May 17, 2026
  • EUDAMED 3cef18e2-d017-438c-84ef-5b3c364cc500 61 fields · synced May 17, 2026
  • EUDAMED b0055458-ee6e-49ad-a0ba-481c27487b2b 61 fields · synced May 17, 2026
  • EUDAMED 42e410a7-1ec0-4714-90e3-6ac5f5732c87 61 fields · synced May 17, 2026
  • EUDAMED f4c44d0b-02c9-4048-9717-5e6eb9b42bbc 61 fields · synced May 17, 2026
  • EUDAMED 30ffaecd-7c1f-4523-a986-dfd34f83fbf7 61 fields · synced May 17, 2026
  • EUDAMED 053df54d-5b5d-4972-baf5-149b016d349c 61 fields · synced May 17, 2026
  • EUDAMED 235e33c0-135c-40d9-abbc-73e5a24d4858 61 fields · synced May 18, 2026
  • EUDAMED 78abb5e9-e459-4d11-8283-07838c27edcd 61 fields · synced May 18, 2026
  • EUDAMED f8cac40a-e5bb-4d11-85e4-067c91fca232 61 fields · synced May 18, 2026
  • EUDAMED eb0efe7d-2268-47da-9d0b-ee02a8734ae0 61 fields · synced May 19, 2026
  • EUDAMED 8911810a-261b-41cd-a077-854fb10757fe 61 fields · synced May 19, 2026
  • EUDAMED 21fbb621-de7e-48d7-866a-21fa4822c1b2 61 fields · synced May 19, 2026
  • EUDAMED 7bdeea88-aebd-4c74-9a79-a64bfb557633 61 fields · synced May 19, 2026
  • EUDAMED bcf27361-ea91-4056-9fe6-5103f7faf110 61 fields · synced May 19, 2026
  • EUDAMED 9149bca2-4c25-4a65-8786-ba6de075b359 61 fields · synced May 19, 2026
  • EUDAMED ab29358f-da73-4660-a451-82e7006de2a3 61 fields · synced May 19, 2026
  • EUDAMED ab62af80-ab3b-4e76-b4b5-782c59ec92e2 61 fields · synced May 19, 2026
  • EUDAMED 1ef65b31-9888-4e23-a751-c200365b3da7 61 fields · synced May 19, 2026
  • EUDAMED 25fc6329-a2c2-4b56-9b97-f55e6460f938 61 fields · synced May 19, 2026
  • EUDAMED 53cb74dc-517d-4e59-b653-ebce116a64c4 61 fields · synced May 19, 2026
  • EUDAMED 38851489-749b-4b72-b1b3-bf745bff71e7 61 fields · synced May 19, 2026