Seats
by Stealth Products, LLC. United States EUDAMEDGUDID
Ref SeatsModel SEA
Product code KNNEMDN Y122406
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number60650900606509900027ES | Date7 Jul 2022 | StatusActive |
| United States | GUDID listing GUDID | Number00606509900027 | Date26 Aug 2019 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Seat
- Generic Name
- Assistive lifting/tilting positioning system
- Device Name
- Seats
- Model / Ref / Catalog
- SEA EUDAMEDSeats EUDAMEDASSISTIVE LIFTING/TILTING POSITIONING SYSTEM GUDIDN/A GUDID
- Primary DI / UDI-DI
- 00606509900027
- Basic UDI-DI
- 60650900606509900027ES
- FDA Product Code
- KNN
- EMDN Code
- Y122406 Belts, seats and armrests for wheelchairs
- GMDN Term
- Assistive lifting/tilting positioning system
- Device Class
- Class I
- Regulation Number
- 890.3920
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | SEA Seats | ASSISTIVE LIFTING/TILTING POSITIONING SYSTEM |
Manufacturer details
- EUDAMED SRN
- US-MF-000018367
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Stealth Products, LLC.
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- 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
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED b164cb6e-5ab0-4759-8f5f-53e48e0d3bee
- FDA UDI 5f698d69-255c-4988-bbd6-8afaa973fdd1