Identity
- Trade Name
- Options IB Prodiva 1.5T R5 EUDAMED
- Device Name
- Prodiva 1.5T EUDAMED
- Model / Reference
- 781081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838112797 EUDAMED
- Basic UDI-DI
- 0884838BM288TC EUDAMED
- Direct Marketing DI
- 00884838112797 EUDAMED
- EMDN Code
- Z11050182 MAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Options IB Prodiva 1.5T R5 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 | 0884838BM288TC | 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 8b78bd77-57f1-43f7-ad4d-abb60a262c6a 61 fields · synced Sep 18, 2026