Identity
- Trade Name
- CT Areta RT/Rembra RT Upgrades EUDAMED
- Device Name
- CT Scanner System (CT Rembra RT/CT Areta RT/CT Rembra) EUDAMED
- Model / Reference
- 728385 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838129559 EUDAMED
- Basic UDI-DI
- 0884838BM1701ME EUDAMED
- EMDN Code
- Z11030606 COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
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 Areta RT/Rembra RT Upgrades by Philips Healthcare (Suzhou) Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 0c218daf-0f16-4913-9383-41473bc0779e 61 fields · synced Jun 19, 2026