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Stationary Anode X-ray tube
EUDAMEDClass IIb (EU MDR)
Ref REM-IFU-RMT08Model RMT-08CModel RMT-08P
by REMEDI Inc.
Identity
- Device Name
- Stationary Anode X-ray tube EUDAMED
- Model / Reference
- RMT-08C EUDAMEDREM-IFU-RMT08 EUDAMEDRMT-08P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800060100267 EUDAMED08800060100274 EUDAMED
- Basic UDI-DI
- B-08800060100267 EUDAMEDB-08800060100274 EUDAMED
- EMDN Code
- Z11039012 X-RAY TUBE ASSEMBLY EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Stationary Anode X-ray tube 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-08800060100267 | 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 (2)
- EUDAMED a4385aa6-8af4-4973-a14c-4833aa77a0ff 61 fields · synced Jul 9, 2026
- EUDAMED 2f4b825e-85d0-4527-913f-f8815742db38 61 fields · synced May 19, 2026