← Back to catalogue
iDR603V-110
EUDAMEDClass IIb (EU MDR)
Ref iDR603V-110Model iDR605T-220, iDR605T-110, iDR605V-220, iDR605V-110, iDR603T- 220, iDR603T- 110, iDR603V-220, iDR603V-110
Identity
- Model / Reference
- iDR605T-220, iDR605T-110, iDR605V-220, iDR605V-110, iDR603T- 220, iDR603T- 110, iDR603V-220, iDR603V-110 EUDAMEDiDR603V-110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975023416098 EUDAMED
- Basic UDI-DI
- 697502341iDR60NC EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Category: Stationary basic diagnostic x-ray system, digital
iDR603V-110 by Yian Medical Technology (haining) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, digital.
- EXSYS DEXi — Drtech Corp. · Class II
- DX-D 400 — Agfa Corp. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- CARESTREAM DRX-EVOLUTION — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- RADspeed fit — Shimadzu Corp. · Class II
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 | 697502341iDR60NC | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yian Medical Technology (Haining) Co., Ltd.
- EUDAMED SRN
- CN-MF-000027269
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED c66d654f-af80-4931-ad52-3543b4403c93 61 fields · synced Jul 31, 2026