Transducer S7-3t
by Philips Ultrasound LLC United States EUDAMEDGUDID
Ref 989605406772
Product code IYNEMDN Z1104020301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0884838BM427T2 | Date17 Apr 2023 | StatusActive |
| United States | GUDID listing GUDID | Number00884838061439 | Date31 Mar 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held
- Device Name
- Invasive (Transesophageal) Transducers
- Model / Reference
- 989605406772
- Primary DI / UDI-DI
- 00884838061439
- Basic UDI-DI
- 0884838BM427T2
- FDA Product Code
- IYN, ITX, IYO
- EMDN Code
- Z1104020301 Transesophageal ultrasound probes, two–dimensional
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 892.1550, 892.1570, 892.1560
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | 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 & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 5531ed44-fae3-4b39-bb1b-bf8c590b1a2a
- FDA UDI b82effe3-f53c-45fe-965a-e172f8c3a8cd