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CT Rembra RT
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 728381Ref 728383510(k) K252992
Identity
- Trade Name
- CT Rembra RT EUDAMEDCT Rembra EUDAMED
- Device Name
- CT Scanner System (CT Rembra RT/CT Areta RT/CT Rembra) EUDAMED
- Model / Reference
- 728381 EUDAMED728383 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838129535 EUDAMED00884838129528 EUDAMED
- Basic UDI-DI
- 0884838BM1701ME EUDAMED
- 510(k) Number
- K252992 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CT Rembra RT by Philips Healthcare (Suzhou) Co., Ltd. — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252992 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM1701ME | Class IIb | Active |
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Manufacturer
- Manufacturer
- Philips Healthcare (Suzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000003923
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED 322bfb57-5e16-4db9-a05b-755dda3c13bc 61 fields · synced Jul 19, 2026
- EUDAMED ebd430a1-d310-4c52-b49b-15584a0cb509 61 fields · synced May 18, 2026
- FDA 510(k) K252992 24 fields · synced May 18, 2026