A13
by Kunshan Aoshida Electric Technology Co., Ltd China EUDAMEDGUDID
Ref DYW50-13Model GT01/A16/A15L/A15/A13/D05/A12S/A12/A11/A10/DE09/A09/DE08L/A08L/DE08/A08/A07/A06L/A06/T3
Product code ITIEMDN Y122127
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697108640DYW50JF | Date13 May 2022 | StatusActive |
| United States | GUDID listing GUDID | Number06971086400135 | Date8 Jan 2018 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- A13 EUDAMEDFreedomchair GUDID
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled
- Model / Ref / Catalog
- GT01/A16/A15L/A15/A13/D05/A12S/A12/A11/A10/DE09/A09/DE08L/A08L/DE08/A08/A07/A06L/A06/T3 EUDAMEDDYW50-13 EUDAMEDA13 GUDIDDYW50-A13 GUDID
- Primary DI / UDI-DI
- 06971086400135
- Basic UDI-DI
- 697108640DYW50JF
- 510(k) Number
- FDA Product Code
- ITI
- EMDN Code
- Y122127 Electric wheelchairs
- GMDN Term
- Electric-motor-driven wheelchair, occupant-controlled
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 890.3860
- Market of Registration
- Austria
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- CN-MF-000004204
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Kunshan Aoshida Electric Technology Co., Ltd
See all devices from Kunshan Aoshida Electric Technology Co., Ltd →
Properties & raw data
Show properties, registry sources and raw records
Other properties (20)
- 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
- Premarket Exempt: No
- Expiration Date: No
Sources (2)
- EUDAMED f9ec7329-a951-4ac6-96a5-13578c09b061
- FDA UDI 95782d2d-c4c0-4254-9995-602be57571df