Identity
- Trade Name
- PHILIP EUDAMEDKnee/Foot coil EUDAMEDPhilips FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Knee/Foot/Ankle coil EUDAMEDFDA UDIKnee/Foot coil EUDAMED
- Model / Reference
- 4522-150-40972 EUDAMEDFDA UDI
- Description
- Knee/Foot/Ankle coil FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970564410024 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06970564410024 EUDAMED
- 510(k) Number
- K071847 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001 MAGNETIC RESONANCE (MR) RADIOFREQUENCY SURFACE COILS EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Netherlands EUDAMEDAustria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Philip by Shanghai Chenguang Medical Technologies Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970564410024 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Chenguang Medical Technologies Co., Ltd
- EUDAMED SRN
- CN-MF-000001299
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED b74a8f4c-01f8-47fa-a144-098c564771fd 61 fields · synced Oct 5, 2026
- FDA UDI 1d1116c8-888b-4713-89fa-37300a909fa8 34 fields · synced May 30, 2026
- EUDAMED 88322eda-53aa-4f25-91b0-8187e29179a1 61 fields · synced Oct 5, 2026