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Annalise Enterprise
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref AnnaliseENTP4Model Annalise Enterprise
Identity
- Trade Name
- Annalise Enterprise EUDAMEDAnnalise Triage FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies. FDA UDI
- Model / Reference
- Annalise Enterprise EUDAMEDAnnaliseENTP4 EUDAMED3.4.1 FDA UDI
- Description
- Annalise Triage is a medical device software application which uses artificial intelligence (AI) algorithms to prioritize suggested findings within a clinical triage workflow of radiological imaging studies. FDA UDI
Identifiers
- Primary DI / UDI-DI
- G140ANNALISEENTP40 EUDAMEDFDA UDI
- Basic UDI-DI
- ++G140AnnaliseEnterprisEM EUDAMED
- FDA Product Code
- QAS FDA UDIQFM FDA UDI
- EMDN Code
- Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2080 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
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
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
Annalise Enterprise by Harrison-AI Medical Pty Ltd — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++G140AnnaliseEnterprisEM | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Harrison-AI Medical Pty Ltd
- EUDAMED SRN
- AU-MF-000010247
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 4bdd6f59-8673-4bec-afe5-ab6fde5c4cba 61 fields · synced Jun 18, 2026
- FDA UDI 5e57a20c-87ba-48c5-a65a-78b92c0d099c 34 fields · synced May 30, 2026