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Aia-Pack Ck-Mb Calibrator Set
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref 0020369
Identity
- Trade Name
- AIA-PACK CK-MB Calibrator Set FDA UDI
- Generic Name
- Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator FDA UDI
- Device Name
- AIA-PACK CK-MB CALIBRATOR SET EUDAMED
- Model / Reference
- 0020369 EUDAMEDN/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211674 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560189211674 EUDAMED
- FDA Product Code
- JHX FDA UDI
- EMDN Code
- W01010115 CREATINE KINASE ISOENZYMES EUDAMED
- GMDN Term
- Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass 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
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
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Aia-Pack Ck-Mb Calibrator Set 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04560189211674 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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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 6f0a0fbf-5f2c-4c37-b393-887290c45d94 61 fields · synced Aug 1, 2026
- FDA UDI 0708e62e-8980-431d-ad92-e59a2d7aac93 34 fields · synced May 29, 2026