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Key ASIC Berhad

FDA UDI

Class I (US FDA UDI)

by Key Asic Berhad

Identity

Trade Name
Key ASIC Berhad FDA UDI
Generic Name
Data storage card FDA UDI
Device Name
The Mcard is a healthcare tool designed to store and transfer medical data, meeting the rigorous standards of the industry. With its robust and reliable features, this card ensures a seamless user experience for healthcare professionals. FDA UDI
Model / Reference
Mcard FDA UDI
Description
The Mcard is a healthcare tool designed to store and transfer medical data, meeting the rigorous standards of the industry. With its robust and reliable features, this card ensures a seamless user experience for healthcare professionals. FDA UDI

Identifiers

Catalog Number
KC00000B400 FDA UDI
Primary DI / UDI-DI
G597KC00000B4000 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Data storage card FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Data storage card

Key ASIC Berhad by Key Asic Berhad — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Data storage card.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Key Asic Berhad

Sources (1)

  • FDA UDI dd5c1afb-7838-4e47-a1d2-1ff73e218044 34 fields · synced Jun 8, 2026