Super Ulstar
by Durico C&T, Inc. South Korea EUDAMEDGUDID
Ref SUPER ULSTAR-840HG
Product code LMDEMDN Z11040185
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number880917855ULSTAR3W | Date27 Feb 2025 | StatusActive |
| United States | GUDID listing GUDID | Number08809178550155 | Date9 Dec 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Medical printer paper
- Device Name
- Thermal Paper for Video Printer (Ultrasound Paper)
- Model / Reference
- SUPER ULSTAR-840HG
- Primary DI / UDI-DI
- 08809178550155
- Basic UDI-DI
- 880917855ULSTAR3W
- FDA Product Code
- LMD
- EMDN Code
- Z11040185 Ultrasound scanners - consumables
- GMDN Term
- Medical printer paper
- Device Class
- Class I
- Regulation Number
- 892.2020
- Market of Registration
- Belgium
- Commercial Distribution
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- KR-MF-000023740
- Authorised representative
- DURICO Imaging BV BE-AR-000022105
Other devices from Durico C&T, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- Sterile: 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 2cf3da58-8205-45b9-a261-3eba77568a78
- FDA UDI f1991fb0-31a5-4928-b309-e5c93ce2d157