S1
by Kunshan Aoshida Electric Technology Co., Ltd China EUDAMEDGUDID
Ref Scooter-S1Model S1/S2
Product code ITIEMDN Y122130
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number697108640SCOOTER35 | Date13 May 2022 | StatusActive |
| United States | GUDID listing GUDID | Number06971086400111 | Date24 Nov 2017 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- S1 EUDAMEDFreedomchair GUDID
- Generic Name
- Electric-motor-driven wheelchair, occupant-controlled
- Device Name
- Scooter
- Model / Ref / Catalog
- S1/S2 EUDAMEDScooter-S1 EUDAMEDS1 GUDID
- Primary DI / UDI-DI
- 06971086400111
- Basic UDI-DI
- 697108640SCOOTER35
- 510(k) Number
- FDA Product Code
- ITI
- EMDN Code
- Y122130 Disability mopeds, 3-wheeled
- 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 |
|---|---|---|
| Model / Reference | S1/S2 Scooter-S1 | S1 |
| 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
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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 c9f51a74-2806-4298-9a06-91a24343c7f9
- FDA UDI ab18c6ff-c602-436d-b0e2-1befca31eb74