Interface Box VT
by Dunlee EUDAMEDGUDID
Active
Ref 300009321791Model 300006530671
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0884838BM908TP | Date8 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00884838114371 | Date9 Jun 2022 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Certificates
- 2243595CE03 Amended
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 9 Aug 2026
- Expires
- 1 Apr 2027
- Reason
- Mnf data change
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- Trade Name
- Interface Box VT EUDAMEDDunlee Sentinelle GUDID
- Generic Name
- MRI system coil, radio-frequency
- Model / Ref / Catalog
- 300006530671, 300009321791, Interface Box VT
- Primary DI / UDI-DI
- 00884838114371
- Basic UDI-DI
- 0884838BM908TP
- Direct Marketing DI
- 00884838114371
- FDA Product Code
- MOS
- EMDN Code
- Z1105018001,Z1105018002,Z1105018099
- GMDN Term
- MRI system coil, radio-frequency
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1000
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | 300006530671 300009321791 | Interface Box VT |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- NL-MF-000051589
Other devices from Dunlee
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No