← Back to catalogue

Aia-Pack Cort Sample Diluting Solution

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref 0020587

by Tosoh Corporation

Identity

Trade Name
AIA-PACK CORT Sample Diluting Solution FDA UDI
Generic Name
Total cortisol IVD, reagent FDA UDI
Device Name
AIA-PACK CORT SAMPLE DILUTING SOLUTION EUDAMED
Model / Reference
0020587 EUDAMED
N/A FDA UDI

Identifiers

Primary DI / UDI-DI
04560189211704 EUDAMEDFDA UDI
Basic UDI-DI
B-04560189211704 EUDAMED
FDA Product Code
JFT FDA UDI
EMDN Code
W0102060203 CORTISOL EUDAMED
GMDN Term
Total cortisol IVD, reagent FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
862.1205 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

No

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

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

Aia-Pack Cort Sample Diluting Solution 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

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

Manufacturer

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

Sources (2)

  • EUDAMED 8b1937f0-fd63-4f56-9a93-762be6e3aa17 61 fields · synced Jun 18, 2026
  • FDA UDI 60c2250c-f09b-4aa7-a8ea-5d071a1c81f6 34 fields · synced May 30, 2026