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Getein

EUDAMED

Class IVD General (EU MDR)

Ref /

by Getein Biotech, Inc.

Identity

Trade Name
Getein EUDAMED
Device Name
MAGICL CA72-4 (CLIA) EUDAMED
MAGICL BNP (CLIA) EUDAMED
MAGICL C-Peptide (CLIA) EUDAMED
MAGICL AFP (CLIA) EUDAMED
MAGICL Anti-TPO (CLIA) EUDAMED
MAGICL CIV (CLIA) EUDAMED
MAGICL CA15-3 (CLIA) EUDAMED
MAGICL CA125 (CLIA) EUDAMED
MAGICL CEA (CLIA) EUDAMED
MAGICL Anti-TSHR (CLIA) EUDAMED
MAGICL 25-OH-VD (CLIA) EUDAMED
MAGICL AFP-L3 (CLIA) EUDAMED
MAGICL CA242 (CLIA) EUDAMED
MAGICL Angiotensin II (CLIA) EUDAMED
MAGICL Calcitonin (CLIA) EUDAMED
MAGICL Cortisol (CLIA) EUDAMED
Model / Reference
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06954414798340 EUDAMED
06954414798319 EUDAMED
06954414713480 EUDAMED
06954414798234 EUDAMED
06954414798098 EUDAMED
06954414798494 EUDAMED
06954414798272 EUDAMED
06954414798289 EUDAMED
06954414798241 EUDAMED
06954414798562 EUDAMED
06954414798203 EUDAMED
06954414798678 EUDAMED
06954414798326 EUDAMED
06954414798883 EUDAMED
06954414798906 EUDAMED
06954414798135 EUDAMED
Basic UDI-DI
B-06954414798340 EUDAMED
B-06954414798319 EUDAMED
B-06954414713480 EUDAMED
B-06954414798234 EUDAMED
B-06954414798098 EUDAMED
B-06954414798494 EUDAMED
B-06954414798272 EUDAMED
B-06954414798289 EUDAMED
B-06954414798241 EUDAMED
B-06954414798562 EUDAMED
B-06954414798203 EUDAMED
B-06954414798678 EUDAMED
B-06954414798326 EUDAMED
B-06954414798883 EUDAMED
B-06954414798906 EUDAMED
B-06954414798135 EUDAMED
EMDN Code
W0102030105 CANCER ANTIGEN 72-4 EUDAMED
W01021301 BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES) EUDAMED
W0102060101 C-PEPTIDE EUDAMED
W0102039001 ALPHAFETOPROTEIN EUDAMED
W0102100301 THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES EUDAMED
W0102120199 LIVER FUNCTION - OTHER EUDAMED
W0102030102 CANCER ANTIGEN 15-3 EUDAMED
W0102030106 CANCER ANTIGEN 125 EUDAMED
W0102030112 CARCINOEMBRYONIC ANTIGEN EUDAMED
W0102100302 TSH RECEPTOR ANTIBODIES EUDAMED
W0102060309 25-HYDROXYVITAMIN D EUDAMED
W0102030108 CANCER ANTIGEN 242 EUDAMED
W0102060202 ANGIOTENSIN I / II EUDAMED
W0102060301 CALCITONIN EUDAMED
W0102060203 CORTISOL EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Netherlands EUDAMED
Romania EUDAMED
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMEDEUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Getein by Getein Biotech, 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

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Manufacturer

Manufacturer
Getein Biotech, Inc.
EUDAMED SRN
CN-MF-000017986
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (16)

  • EUDAMED 71dfe9a8-490f-4008-929a-11f42bf3c6ae 61 fields · synced Aug 1, 2026
  • EUDAMED 82e4e09e-5c87-4d96-84d4-8d28ea2cab96 61 fields · synced May 11, 2026
  • EUDAMED 60e6f38d-8519-4fa9-b95d-9d4ae9a3bc2c 61 fields · synced May 16, 2026
  • EUDAMED 692f1cb3-8ea4-4f95-b590-58f32a1108f6 61 fields · synced May 17, 2026
  • EUDAMED b6183e8e-7a5f-4a63-9af4-6e2a506c3d01 61 fields · synced May 17, 2026
  • EUDAMED 9e96d882-ac1a-4b51-a7fe-e8a4f26f0383 61 fields · synced May 17, 2026
  • EUDAMED 08660dbb-129e-441f-a587-b3e8e0af3ab5 61 fields · synced May 17, 2026
  • EUDAMED ed1d3c6e-5b5f-4d8d-b255-355050dfa400 61 fields · synced May 17, 2026
  • EUDAMED 69568585-9ebc-49f9-994e-d7cc2e9eb20e 61 fields · synced May 17, 2026
  • EUDAMED 1b0acdd4-0aed-4cf3-b9b6-53725e52c8a7 61 fields · synced May 17, 2026
  • EUDAMED 3bd80807-9411-4718-8dc5-7f61287c9b42 61 fields · synced May 18, 2026
  • EUDAMED b0d0e82d-c4d5-45f6-83e6-b4136a03fdba 61 fields · synced May 18, 2026
  • EUDAMED a933c5af-b8be-4487-bfe2-ebb96dfb5703 61 fields · synced May 18, 2026
  • EUDAMED c7e14417-8774-4d70-be84-14f78f80b72a 61 fields · synced May 18, 2026
  • EUDAMED 0f429158-bdbd-4cf3-a423-ac0080718aa5 61 fields · synced May 18, 2026
  • EUDAMED 56d9dde5-c0bf-4948-908f-588025323246 61 fields · synced May 18, 2026