Identity
- Trade Name
- Smart Fit Knee 3.0T EUDAMED
- Device Name
- MR coil (Smart Fit Knee 3.0T) EUDAMED
- Model / Reference
- 989710012251 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00884838112667 EUDAMED
- Basic UDI-DI
- 0884838BM1820MP EUDAMED
- EMDN Code
- Z1105018002 MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS EUDAMED
Classification
- Device Class
- Class IIa 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
Category: MRI system coil, radio-frequency
Smart Fit Knee 3.0T by Philips Healthcare (Suzhou) Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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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 | K233600 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM1820MP | Class IIa | 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 (2)
- EUDAMED 316e9d87-3ffe-42a5-9da0-44b083c13c09 61 fields · synced Jul 8, 2026
- FDA 510(k) K233600 1 fields · synced May 18, 2026