← Back to catalogue

Ck Nac Sl

EUDAMEDFDA UDI

Class B (EU MDR)

Ref CKSL-0230

by VitalScientific

Identity

Trade Name
CK NAC SL EUDAMEDFDA UDI
Generic Name
Total creatine kinase (CK) IVD, kit, spectrophotometry FDA UDI
Device Name
CK NAC SL EUDAMED
Model / Reference
CKSL-0230 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
03701700819004 EUDAMEDFDA UDI
Basic UDI-DI
37017008CKSL0095 EUDAMED
EMDN Code
W01010113 CREATINE KINASE - TOTAL EUDAMED
GMDN Term
Total creatine kinase (CK) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class B EUDAMED
Market of Registration
France 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

No

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

Yes

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

Ck Nac Sl by Vitalscientific — Class B — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
VitalScientific
EUDAMED SRN
FR-MF-000004722

Sources (2)

  • EUDAMED 22c791a4-6263-44be-94cf-130a3c18ff5d 61 fields · synced Jul 9, 2026
  • FDA UDI 0980e0e5-8d40-404b-908d-08452a70ee6e 32 fields · synced May 30, 2026