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dS SMALL EXTREMITY 16CH 3.0T, COIL
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 459801728801Ref 459801728802Ref 459800778111
Identity
- Trade Name
- dS SMALL EXTREMITY 16CH 3.0T, COIL EUDAMEDdS Small Extremity 16Ch 3.0T EUDAMEDInvivo FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- dS SMALL EXTREMITY 16CH 3.0T, COIL EUDAMEDdS Small Extremity 16Ch 3.0T EUDAMEDFDA UDI
- Model / Reference
- 459801728801 EUDAMED459801728802 EUDAMED459800778111 EUDAMEDdS Small Extremity 16Ch 3.0T FDA UDI45980077811 FDA UDI
- Description
- dS Small Extremity 16Ch 3.0T FDA UDI
Identifiers
- Catalog Number
- 459801728802 FDA UDI
- Primary DI / UDI-DI
- 00884838098060 EUDAMED00884838107878 EUDAMEDFDA UDI00884838081666 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838098060 EUDAMEDB-00884838107878 EUDAMEDB-00884838081666 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
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
Yes
FDA UDIFDA 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 SMALL EXTREMITY 16CH 3.0T, COIL by Invivo Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838098060 | Class IIa | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Invivo Corporation
- EUDAMED SRN
- US-MF-000002284
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (5)
- EUDAMED 286f3d90-181e-4734-af93-04e4b7773322 61 fields · synced Aug 1, 2026
- EUDAMED f3548d17-8a0e-4f6e-9af5-8beff851409d 61 fields · synced May 18, 2026
- FDA UDI 19044df2-282b-43bc-bea8-09d8fa5a400d 36 fields · synced May 30, 2026
- FDA UDI 97804df9-932b-48a8-8f7a-85af69ae1903 35 fields · synced May 30, 2026
- EUDAMED a3cf58b9-0d04-4af9-be19-bdbc4dc5e329 61 fields · synced Aug 1, 2026