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St Aia-Pack Ck-Mb

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 0025269

by Tosoh Corporation

Identity

Trade Name
ST AIA-PACK CK-MB FDA UDI
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
ST AIA-PACK CK-MB EUDAMED
Model / Reference
0025269 EUDAMED
N/A FDA UDI

Identifiers

Primary DI / UDI-DI
14560189210728 EUDAMEDFDA UDI
Basic UDI-DI
B-14560189210728 EUDAMED
FDA Product Code
JHX FDA UDI
EMDN Code
W01010115 CREATINE KINASE ISOENZYMES EUDAMED
GMDN Term
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.1215 FDA UDI
Market of Registration
Belgium EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

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

Prescription Use

No

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

St Aia-Pack Ck-Mb by Tosoh Corporation — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tosoh Corporation
EUDAMED SRN
JP-MF-000024143
Authorised Representative
Tosoh Europe N.V. BE-AR-000000211

Sources (2)

  • EUDAMED 27ad5b0c-99f8-40ba-8f6a-4ea466b443ce 61 fields · synced Jun 17, 2026
  • FDA UDI f519a249-0ab8-4adf-9bca-a66e683f0b41 34 fields · synced May 30, 2026