MMPT3-7
by Samsung Medison Co., Ltd South Korea EUDAMEDGUDID
Ref N/AModel Ultrasound probe
Product code IYNEMDN Z1104020301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number08809944935292 | Date3 Sep 2025 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number880972578USP001WH | Date16 May 2025 | StatusActive |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / Reference
- Ultrasound probe EUDAMEDN/A EUDAMEDMMPT3-7 GUDID
- Primary DI / UDI-DI
- 08809944935292
- Basic UDI-DI
- 880972578USP001WH
- FDA Product Code
- IYN, IYO, ITX, QIH, LLZ
- 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, 892.1560, 892.1570, 892.2050
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Ultrasound probe N/A | MMPT3-7 |
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- KR-MF-000011620
- Authorised representative
- Samsung Electronics GmbH DE-AR-000007005
Other devices from Samsung Medison Co., Ltd.
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 ce689bd8-c10c-4f71-bd22-c9280a8533c9
- FDA UDI 44ee77fb-9f53-491b-b1ff-f5f2c5393e18