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EOSedge Chair
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 9000116089Model EOSedge Chair
by EOS imaging
Identity
- Trade Name
- EOSedge Chair EUDAMEDFDA UDI
- Generic Name
- Diagnostic x-ray system chair FDA UDI
- Device Name
- EOSedge Chair EUDAMED
- Model / Reference
- EOSedge Chair EUDAMED9000116089 EUDAMED2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03663999000139 EUDAMEDFDA UDI
- Basic UDI-DI
- 3663999RCH0244 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- V080202 MANUAL MEDICAL CHAIRS EUDAMED
- GMDN Term
- Diagnostic x-ray system chair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
EOSedge Chair by Eos Imaging — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192079 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K233920 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K202394 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 3663999RCH0244 | Class I | Active |
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Manufacturer
- Manufacturer
- EOS imaging
- EUDAMED SRN
- FR-MF-000000502
Sources (3)
- EUDAMED b35b7239-abaf-4d0a-9503-5a26a74c73fe 61 fields · synced Jun 19, 2026
- FDA UDI 66fd44d8-f14f-454e-9fe5-9ed67a659374 32 fields · synced May 27, 2026
- FDA 510(k) K192079 1 fields · synced May 18, 2026