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ePROGESA

FDA UDI

Class II (US FDA UDI)

by Mak-System Group Limited

Identity

Trade Name
ePROGESA FDA UDI
Generic Name
Blood bank information system FDA UDI
Model / Reference
v5.0.3 FDA UDI

Identifiers

Primary DI / UDI-DI
03665324000050 FDA UDI
FDA Product Code
MMH FDA UDI
GMDN Term
Blood bank information system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9165 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Blood bank information system

ePROGESA by Mak-System Group Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood bank information system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9e762637-0994-45df-b7f4-e6cb24f562a8 33 fields · synced May 29, 2026