Identity
- Trade Name
- Incisive CT and CT 5300 upgrades EUDAMED
- Device Name
- CT Scanner System (Incisive CT/CT5300) EUDAMED
- Model / Reference
- 728286 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838121430 EUDAMED
- Basic UDI-DI
- 0884838BM285T6 EUDAMED
- Direct Marketing DI
- 00884838121430 EUDAMED
- EMDN Code
- Z11030606,Z11030699 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Incisive CT and CT 5300 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 | 0884838BM285T6 | 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 17bd77a4-05ed-483f-80db-0a9bc022f0ce 61 fields · synced Jun 18, 2026