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B·r·a·h·m·s Ca 125 Ii Kryptor Cal

EUDAMED

Class C (EU MDR)

Ref 080591NRef 805075N

by B·R·A·H·M·S GmbH

Identity

Trade Name
B·R·A·H·M·S CA 125 II KRYPTOR CAL EUDAMED
B·R·A·H·M·S CA 125 II KRYPTOR EUDAMED
Device Name
B·R·A·H·M·S CA 125 II KRYPTOR CAL EUDAMED
B·R·A·H·M·S CA 125 II KRYPTOR EUDAMED
Model / Reference
080591N EUDAMED
805075N EUDAMED

Identifiers

Primary DI / UDI-DI
04260157630680 EUDAMED
04260157631861 EUDAMED
Basic UDI-DI
426015763805BC125KCALXXWT EUDAMED
426015763805BCA125IIKXX2M EUDAMED
EMDN Code
W0102152299 STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER EUDAMED
W0102030106 CANCER ANTIGEN 125 EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

B·r·a·h·m·s Ca 125 Ii Kryptor Cal by B.R.A.H.M.S GmbH — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
DE-MF-000026030

Sources (2)

  • EUDAMED 1c610143-e84f-457b-b7b5-9250dfed628a 61 fields · synced Jul 23, 2026
  • EUDAMED be99430c-8318-4bfd-8bbc-fd1bec2702c1 61 fields · synced May 19, 2026