Identity
- Trade Name
- CareView 3600RF EUDAMEDX-ray Flat Panel Detector FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- X-ray Flat Panel Detector EUDAMED
- Model / Reference
- CareView 1800RF EUDAMED047 EUDAMEDCareView 3600RF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970597830479 EUDAMEDFDA UDI
- Basic UDI-DI
- 697059783DynamicCR EUDAMED
- Direct Marketing DI
- 06970597830479 EUDAMED
- 510(k) Number
- K202995 FDA UDI
- FDA Product Code
- MQB FDA UDI
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Market of Registration
- Northern Ireland 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
CareView 3600RF by Careray Digital Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697059783DynamicCR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- CareRay Digital Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007229
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 925c4e7f-7f8d-4eeb-93b7-06a38ad6a4f7 61 fields · synced Jun 20, 2026
- FDA UDI e175289a-077c-426d-9b97-454949003ac7 33 fields · synced May 30, 2026