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B·R·A·H·M·S CgA II KRYPTOR

EUDAMEDFDA UDI

Class C (EU MDR)

Ref 839050N

by B·R·A·H·M·S GmbH

Identity

Trade Name
B·R·A·H·M·S CgA II KRYPTOR EUDAMED
B.R.A.H.M.S CgA II KRYPTOR FDA UDI
Generic Name
Chromogranin A IVD, kit, fluorescent immunoassay FDA UDI
Device Name
B·R·A·H·M·S CgA II KRYPTOR EUDAMED
Model / Reference
839050N EUDAMEDFDA UDI

Identifiers

Catalog Number
839050N FDA UDI
Primary DI / UDI-DI
04260157632127 EUDAMEDFDA UDI
Basic UDI-DI
426015763839BCgAIIK00XXNL EUDAMED
510(k) Number
K222251 FDA UDI
FDA Product Code
QXS FDA UDI
EMDN Code
W0102039014 CHROMOGRANIN A EUDAMED
GMDN Term
Chromogranin A IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class C EUDAMED
Class II FDA UDI
Regulation Number
866.6010 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

B·R·A·H·M·S CgA II KRYPTOR by B.R.A.H.M.S GmbH — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B·R·A·H·M·S GmbH
EUDAMED SRN
DE-MF-000026030

Sources (2)

  • EUDAMED 641aea4c-8306-47ce-9cd6-8507b6366010 61 fields · synced Oct 6, 2026
  • FDA UDI 7bbf5760-ca30-42ab-a1d9-ffcb2e4fca52 34 fields · synced May 29, 2026