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B·R·A·H·M·S sFlt-1 KRYPTOR QC

EUDAMEDFDA UDI

Class C (EU MDR)

Ref 084592N

by B·R·A·H·M·S GmbH

Identity

Trade Name
B·R·A·H·M·S sFlt-1 KRYPTOR QC EUDAMED
B.R.A.H.M.S sFlt-1 KRYPTOR QC FDA UDI
Generic Name
Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, control FDA UDI
Device Name
B·R·A·H·M·S sFlt-1 KRYPTOR QC EUDAMED
Model / Reference
084592N EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
04260157632486 EUDAMEDFDA UDI
Basic UDI-DI
426015763845BsFlt1KQCXXHH EUDAMED
FDA Product Code
JJX FDA UDI
EMDN Code
W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
GMDN Term
Soluble vascular endothelial growth factor receptor 1 (sVEGFR-1) IVD, control FDA UDI

Classification

Device Class
Class C EUDAMED
Class I FDA UDI
Regulation Number
862.1660 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

Yes

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

Yes

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 sFlt-1 KRYPTOR QC 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 d59ac1b7-1c68-488f-983d-8a39fbc78765 61 fields · synced Oct 6, 2026
  • FDA UDI 7da12ed9-d9a3-4f89-a976-c9afb0686201 32 fields · synced May 30, 2026