DR 100s
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
by Agfa NV
Identity
- Trade Name
- DR 100s EUDAMEDFDA UDI
- Generic Name
- Mobile basic diagnostic x-ray system, digital FDA UDI
- Device Name
- DR 100s 6013 EUDAMEDMobile DR FDA UDI
- Model / Reference
- MAC3H EUDAMED6013/100 FDA UDI
- Description
- Mobile DR FDA UDI
Identifiers
- Catalog Number
- MAC3H FDA UDI
- Primary DI / UDI-DI
- 05414904271032 EUDAMEDFDA UDI
- Basic UDI-DI
- 5414904272787Z6 EUDAMED
- 510(k) Number
- K191884 FDA UDI
- FDA Product Code
- IZL FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Mobile basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1720 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Stationary basic diagnostic x-ray system, digital
DR 100s by Agfa NV — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — 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
- iDR603V-110 — YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD. · Class IIb
Manufacturer's product page: DR 100s Motorized
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191884 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 5414904272787Z6 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Agfa NV
- EUDAMED SRN
- BE-MF-000000571
- FDA Applicant
- Agfa N.V.
Sources (3)
- EUDAMED 72d003ec-95dc-47d7-8800-7df450cbb1e4 85 fields · synced Jun 18, 2026
- FDA UDI bda8c395-395e-4648-8efc-12c80f2dd3bb 36 fields · synced May 30, 2026
- FDA 510(k) K191884 1 fields · synced May 18, 2026