Identity
- Trade Name
- ePROGESA FDA UDI
- Generic Name
- Blood bank information system FDA UDI
- Model / Reference
- 5.0.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03665324000036 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
Yes
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.
- Vista ® — Terumo BCT, Inc.. · Class II
- Vista ® — Terumo BCT, Inc.. · Class II
- Vista® — Terumo BCT, Inc.. · Class II
- ElDorado Donor 3.x.x — GPI USA, INC. · Class II
- Trucise® 2.0 Total System — Terumo BCT, Inc.. · Class II
- e-Delphyn LIS Donor — GPI USA, INC. · Class II
- e-Delphyn Donor — GPI USA, INC. · Class II
- Surround 5.x — GPI USA, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mak-System Group Limited
Sources (1)
- FDA UDI ef54718e-52d4-47b0-a1dd-ee3ed51d57e8 33 fields · synced May 30, 2026