Identity
- Trade Name
- ImmuLINK® EUDAMEDImmuLINK FDA UDI
- Generic Name
- Blood bank information system application software FDA UDI
- Device Name
- ImmuLINK® EUDAMEDImmuLINK stand-alone software is for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software and Laboratory Information System. ImmuLINK includes the following features and/or functions: It provides the ability to create and print reports of tests and results. It supports the ability to compare current results with previous results. It supports the automatic ordering of reflex tests. It provides a tool so that test results produced by a testing platform can be remotely validated prior to delivery to an LIS. Results can also be viewed remotely and edited prior to delivery to an LIS. It provides bi-directional communication with LIS and instrument platform(s). FDA UDI
- Model / Reference
- 0064319 EUDAMEDFDA UDI
- Description
- ImmuLINK stand-alone software is for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software and Laboratory Information System. ImmuLINK includes the following features and/or functions: It provides the ability to create and print reports of tests and results. It supports the ability to compare current results with previous results. It supports the automatic ordering of reflex tests. It provides a tool so that test results produced by a testing platform can be remotely validated prior to delivery to an LIS. Results can also be viewed remotely and edited prior to delivery to an LIS. It provides bi-directional communication with LIS and instrument platform(s). FDA UDI
Identifiers
- Catalog Number
- 0064319 FDA UDI
- Primary DI / UDI-DI
- 10888234001034 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0202030182A000TP 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
- Germany 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
No
FDA UDI
ImmuLINK® by Immucor, Inc. — 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 | 88823401W0202030182A000TP | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED 74ada335-45a2-41ac-98bf-5090acc09b6e 61 fields · synced Jul 9, 2026
- FDA UDI db8449dc-b316-4480-b7ab-f8684f9563fa 36 fields · synced May 30, 2026