Identity
- Trade Name
- dS Breast 16ch 3.0T EUDAMEDInvivo FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- Philips Breast Coil EUDAMEDdS Breast 16ch 3.0T FDA UDI
- Model / Reference
- 459801729891 EUDAMEDdS Breast 16ch 3.0T FDA UDI
- Description
- dS Breast 16ch 3.0T FDA UDI
Identifiers
- Catalog Number
- 459801729891 FDA UDI
- Primary DI / UDI-DI
- 00884838098381 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM410SH EUDAMED
- Direct Marketing DI
- 00884838098381 EUDAMED
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z1105018001,Z1105018002,Z1105018099 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 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
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
Prescription Use
Yes
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
dS Breast 16ch 3.0T by Invivo Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM410SH | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Invivo Corporation
- EUDAMED SRN
- US-MF-000002284
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 260599a2-0109-4e7d-b17c-e8f8eaab7389 61 fields · synced Jul 28, 2026
- FDA UDI b6a52fda-aff7-42d6-b962-88d5427aa30a 36 fields · synced May 27, 2026