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Portable X-ray equipment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref REM-IFU-T(K)100_Instruction For UseModel REMEX-T100Ref REM-IFU-KA6Model REMEX-KA6
by REMEDI Inc.
Identity
- Trade Name
- REMEX-KA6 EUDAMEDREMEX KA6 FDA UDI
- Generic Name
- Portable basic diagnostic x-ray system, digital FDA UDI
- Device Name
- Portable X-ray equipment EUDAMED
- Model / Reference
- REMEX-T100 EUDAMEDREM-IFU-T(K)100_Instruction For Use EUDAMEDREMEX-KA6 EUDAMEDREM-IFU-KA6 EUDAMEDREMEX KA6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800060100014 EUDAMED08800060100151 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800060100014 EUDAMED88000601REMEX-WBS6 EUDAMEDB-08800060100151 EUDAMED
- Direct Marketing DI
- 08800060100151 EUDAMED
- 510(k) Number
- K212144 FDA UDI
- FDA Product Code
- IZI FDA UDI
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
- GMDN Term
- Portable basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1600 FDA UDI
- Market of Registration
- Portugal EUDAMEDItaly 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
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
No
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 X-ray equipment by REMEDI Inc. — Class IIb — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800060100014 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-08800060100014 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- REMEDI Inc.
- EUDAMED SRN
- KR-MF-000026327
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (4)
- EUDAMED 25336adc-65a2-4d8e-8f74-4270dc93b4f7 61 fields · synced Jul 27, 2026
- EUDAMED 1a520f15-f685-4c87-9fad-0a570e57a4f8 61 fields · synced May 11, 2026
- FDA UDI 42d04806-193c-44a3-b1ed-9bcc1fb8985e 34 fields · synced May 29, 2026
- EUDAMED 0435968e-71e1-4c4e-b4ec-143ed0f0af02 61 fields · synced Jul 13, 2026