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Portable dental X-ray system
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref IFU-07Model DX-7020
by Dexcowin
Identity
- Trade Name
- Cocoon FDA UDI
- Generic Name
- Hand-held intraoral dental x-ray system, digital FDA UDI
- Device Name
- Portable dental X-ray system EUDAMEDPortable x-ray system indicated for taking diagnostic dental x-ray for both pediatric and adult patients using intraoral film or PSP or digital sensors. FDA UDI
- Model / Reference
- DX-7020 EUDAMEDFDA UDIIFU-07 EUDAMED
- Description
- Portable x-ray system indicated for taking diagnostic dental x-ray for both pediatric and adult patients using intraoral film or PSP or digital sensors. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800000500065 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800000500065 EUDAMED
- FDA Product Code
- MUH FDA UDI
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
- GMDN Term
- Hand-held intraoral dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.1800 FDA UDI
- Market of Registration
- Poland 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Portable dental 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-08800000500065 | 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 (2)
- EUDAMED f5c1247f-f276-4b41-ab97-94c44c5068ea 61 fields · synced Jul 16, 2026
- FDA UDI c082029c-454d-4a50-9665-c32489b4a450 35 fields · synced May 30, 2026