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Remex-K100
EUDAMEDClass IIb (EU MDR)
Ref REM-IFU-T(K)100Model REMEX-K100
by REMEDI Inc.
Identity
- Trade Name
- REMEX-K100 EUDAMED
- Device Name
- Portable X-ray equipment EUDAMED
- Model / Reference
- REMEX-K100 EUDAMEDREM-IFU-T(K)100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800060100021 EUDAMED
- Basic UDI-DI
- B-08800060100021 EUDAMED
- EMDN Code
- Z11039016 MOBILE RADIOGRAPHIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Portugal EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Remex-K100 by REMEDI Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800060100021 | Class IIb | Active |
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Manufacturer
- Manufacturer
- REMEDI Inc.
- EUDAMED SRN
- KR-MF-000026327
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 0bad8de1-aa66-499e-bd10-7b117a39f0b9 61 fields · synced Jun 18, 2026