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Ref 989606735311
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0884838BM789U7 00884838112025 | Date1 Apr 2024 | StatusActive |
| United States | GUDID listing GUDID | Number00884838112025 | Date28 Oct 2022 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- General-purpose ultrasound imaging system
- Device Name
- Ultrasound System Carts
- Model / Reference
- 989606735311
- Primary DI / UDI-DI
- 00884838112025
- Basic UDI-DI
- 0884838BM789U7
- FDA Product Code
- IYN, IYO, ITX
- EMDN Code
- Z1104018099 Ultrasound scanners – hardware accessories – other
- GMDN Term
- General-purpose ultrasound imaging system
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 892.1550, 892.1560, 892.1570
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000002237
- Authorised representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Other devices from Philips Ultrasound LLC
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