Identity
- Trade Name
- Digital Imaging System EUDAMEDACQUIDR EUDAMED
- Device Name
- Digital Imaging System EUDAMED
- Model / Reference
- ACQUIDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800011130008 EUDAMED
- Basic UDI-DI
- 88000111DISACQ300022 EUDAMED
- EMDN Code
- Z11039021 RADIOGRAPHY VIDEO ACQUISITION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Digital Imaging System by DRGEM Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000111DISACQ300022 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DRGEM Corporation
- EUDAMED SRN
- KR-MF-000017990
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 77b1b3d6-56b2-46bc-a220-bce6c4f1622e 61 fields · synced Jul 29, 2026
- EUDAMED 21744315-db26-488f-9f7f-4ad94828122e 61 fields · synced Jul 29, 2026