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Portable X-Ray system
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IFU-08Model ADX6000FBRef IFU-04Model ADX4000W
by Dexcowin
Identity
- Trade Name
- ADX4000; iRay D4 FDA UDI
- Generic Name
- Diagnostic x-ray system generator, portable FDA UDI
- Device Name
- Portable X-Ray system EUDAMEDPortable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients. FDA UDI
- Model / Reference
- ADX6000FB EUDAMEDIFU-08 EUDAMEDADX4000W EUDAMEDIFU-04 EUDAMEDADX4000; ADX4000W FDA UDI
- Description
- Portable x-ray system intended for dental radio-graphic examination and diagnosis of diseases of the teeth, jaw and oral structure for both pediatric and adult patients. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000500133 EUDAMED08800000500010 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800000500133 EUDAMEDB-08800000500010 EUDAMED
- 510(k) Number
- K134055 FDA UDI
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
- GMDN Term
- Diagnostic x-ray system generator, portable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- Italy EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Portable X-Ray system by Dexcowin — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800000500133 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Dexcowin
- EUDAMED SRN
- KR-MF-000032389
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (3)
- EUDAMED 3bd45191-6c8d-4c26-8dbc-baf23d7cd21a 61 fields · synced Jul 10, 2026
- FDA UDI 28557721-7196-4d80-b7a6-592279220bfc 36 fields · synced May 30, 2026
- EUDAMED 5031e698-ebf6-4198-926d-8b41da6f6b9d 61 fields · synced Jul 10, 2026