Identity
- Trade Name
- Radiological PACS Software EUDAMEDGEMPACS EUDAMEDDRGEM FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Radiological PACS Software EUDAMED
- Model / Reference
- GEMPACS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800011170028 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000111RPSGEM6000P2 EUDAMED
- FDA Product Code
- LMD FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.2020 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiological PACS Software by DRGEM Corporation — Class I — 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 | 88000111RPSGEM6000P2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DRGEM Corporation
- EUDAMED SRN
- KR-MF-000017990
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 7026b62b-148a-4abd-aca5-2b42464b3f3c 61 fields · synced Jul 12, 2026
- FDA UDI 1d61a500-8ebf-47f7-ab97-9c7654185c73 32 fields · synced May 30, 2026
- EUDAMED 59843c17-321a-428d-8e3f-09aeac8c2ff1 61 fields · synced Jul 12, 2026