Identity
- Trade Name
- STARPACS Orthopedics System FDA UDISTARPACS FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- STARPACS EUDAMED
- Model / Reference
- 401 EUDAMEDSTARPACS Orthopedics System FDA UDISTARPACS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809278790000 EUDAMEDFDA UDI08809278790017 FDA UDI
- Basic UDI-DI
- B-08809278790000 EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Belgium 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological PACS software
STARPACS Orthopedics System by INFINITT Healthcare Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiological PACS software.
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- interWORKS — Avreo, Inc. · Class I
- NovaPACS — Novarad Corporation · Class II
- OrthoNext™ Platform System Software — Orthofix, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- INFINITT Healthcare Co., Ltd.
Sources (3)
- FDA UDI 9a114ca9-3e77-4487-8130-3ab5218153bf 33 fields · synced Jul 20, 2026
- FDA UDI e294ac40-7fcc-4b20-8322-e88914c4a731 33 fields · synced May 30, 2026
- EUDAMED 68292c05-33e6-4f9a-ba08-d79fcacab544 61 fields · synced Jul 20, 2026