Identity
- Trade Name
- Blood Typing Manager EUDAMEDFDA UDI
- Generic Name
- Blood bank information system application software FDA UDI
- Device Name
- Blood Typing Manager EUDAMEDBlood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager includes the following features: • Bidirectional connectivity with one or more LIS. • Provides the ability to centralize the management of Quality Control. • Allows user to view and validate results remotely prior to export to LIS. • Allows to create and print reports. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System. FDA UDI
- Model / Reference
- 210404 EUDAMEDFDA UDI
- Description
- Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager includes the following features: • Bidirectional connectivity with one or more LIS. • Provides the ability to centralize the management of Quality Control. • Allows user to view and validate results remotely prior to export to LIS. • Allows to create and print reports. Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System as part of the DG Gel System. FDA UDI
Identifiers
- Catalog Number
- 210404 FDA UDI
- Primary DI / UDI-DI
- 08436583731215 EUDAMEDFDA UDI
- Basic UDI-DI
- 843658373BTMRP EUDAMED
- FDA Product Code
- MMH FDA UDI
- EMDN Code
- W0202030182 BLOOD GROUPING ANALYSERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Blood bank information system application software FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9165 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Blood Typing Manager by Diagnostic Grifols, S.a. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 843658373BTMRP | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Diagnostic Grifols, S.A.
- EUDAMED SRN
- ES-MF-000000784
Sources (2)
- EUDAMED 5bb89e05-009c-41c0-b169-02712e2edbd9 61 fields · synced Jun 8, 2026
- FDA UDI 71b137c0-c754-4ec7-80d1-6aafeb1ad68b 35 fields · synced May 30, 2026