Identity
- Trade Name
- SENSE HEAD COIL 32CH 3.0 T EUDAMEDInvivo FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- SENSE HEAD COIL 32CH 3.0 T EUDAMEDSENSE Head Coil 3.0T 32 FDA UDI
- Model / Reference
- 453530259709 EUDAMED45353025970 FDA UDI
- Description
- SENSE Head Coil 3.0T 32 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838065932 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838065932 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
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
Sense Head Coil 32ch 3.0 T 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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-00884838065932 | Class IIa | No Longer Active |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 7482b720-fa94-4138-8a28-953c5fa9c5b7 61 fields · synced Jul 10, 2026
- FDA UDI 100261d4-c15a-4047-9b64-bd82c4857224 35 fields · synced May 27, 2026