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Mobility Scooter
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref SW3300Ref AIR CLASSIC (Deluxe Blue)Ref 1001BRef 1000T Ref AIR CLASSIC (BASIC BLACK)Ref AIR CLASSIC (General Red)Ref 1000DRef SW1000LRef SW1000SLRef SW1102CRef S1 LITE BLUERef SW1000ERef 1001DRef 1003BRef S70Ref 1005BRef JD001Ref SW1400DRef S28Ref S1 PlusRef AIR CLASSIC (BASIC GREY)Ref 1000BRef 1002BRef 1001NRef S20Ref Max SportRef AIR CLASSIC (General Blue)Ref SW1000A-1Ref S50
Identity
- Trade Name
- Mobility Scooter EUDAMEDSweetrich EUDAMEDFDA UDIMetro Mobility FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Mobility Scooter EUDAMEDPower Wheelchair EUDAMED
- Model / Reference
- SW3300 EUDAMEDAIR CLASSIC (Deluxe Blue) EUDAMED1001B EUDAMED1000T EUDAMEDAIR CLASSIC (BASIC BLACK) EUDAMEDAIR CLASSIC (General Red) EUDAMED1000D EUDAMEDSW1000L EUDAMEDSW1000SL EUDAMEDSW1102C EUDAMEDS1 LITE BLUE EUDAMEDSW1000E EUDAMED1001D EUDAMED1003B EUDAMEDS70 EUDAMED1005B EUDAMEDJD001 EUDAMEDSW1400D EUDAMEDS28 EUDAMEDS1 Plus EUDAMEDFDA UDIMAX SPORT EUDAMEDFDA UDIAIR CLASSIC (BASIC GREY) EUDAMED1000B EUDAMED1002B EUDAMED1001N EUDAMEDS20 EUDAMEDAIR CLASSIC (General Blue) EUDAMEDSW1000A-1 EUDAMEDS50 EUDAMEDMax Sport(Red) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973079889286 EUDAMED06973079880078 EUDAMED06973079880351 EUDAMED06973079880306 EUDAMED06973079880139 EUDAMED06973079880047 EUDAMED06973079880153 EUDAMED06973079889767 EUDAMED06973079880191 EUDAMED06973079889712 EUDAMED06973079880122 EUDAMED06973079889927 EUDAMED06973079880337 EUDAMED06973079880375 EUDAMED06973079889378 EUDAMED06973079880399 EUDAMED06973079889606 EUDAMED06973079889330 EUDAMED06973079889750 EUDAMED06973079889620 EUDAMEDFDA UDI06973079889682 EUDAMEDFDA UDI06973079880146 EUDAMED06973079880344 EUDAMED06973079880016 EUDAMED06973079880368 EUDAMED06973079880184 EUDAMED06973079889538 EUDAMED06973079880030 EUDAMED06973079889965 EUDAMED06973079889552 EUDAMED06973079880245 FDA UDI
- Basic UDI-DI
- 697307988SWSCOOTERXN EUDAMED697307988SWWHEELCHAIRTB EUDAMED
- Direct Marketing DI
- 06973079889286 EUDAMED06973079880078 EUDAMED06973079880351 EUDAMED06973079880306 EUDAMED06973079880139 EUDAMED06973079880047 EUDAMED06973079880153 EUDAMED06973079889767 EUDAMED06973079880191 EUDAMED06973079889712 EUDAMED06973079880122 EUDAMED06973079889927 EUDAMED06973079880337 EUDAMED06973079880375 EUDAMED06973079889378 EUDAMED06973079880399 EUDAMED06973079889606 EUDAMED06973079889330 EUDAMED06973079889750 EUDAMED06973079889682 EUDAMED06973079880146 EUDAMED06973079880344 EUDAMED06973079880016 EUDAMED06973079880368 EUDAMED06973079880184 EUDAMED06973079889538 EUDAMED06973079889620 EUDAMED06973079880030 EUDAMED06973079889965 EUDAMED06973079889552 EUDAMED
- 510(k) Number
- K231472 FDA UDI
- FDA Product Code
- INI FDA UDI
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMEDY122127 ELECTRIC WHEELCHAIRS EUDAMED
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mobility Scooter by Suzhou Sweetrich Vehicle Industry Technology Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253075 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697307988SWSCOOTERXN | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000011210
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (34)
- EUDAMED c338908d-ea53-40bf-b041-64e01225776c 61 fields · synced Oct 6, 2026
- EUDAMED 0b0bef54-e457-41d2-adfe-9823e234f91f 61 fields · synced May 16, 2026
- EUDAMED 042e4055-a246-4dd0-a3f7-4b7726d75f01 61 fields · synced May 16, 2026
- EUDAMED 488b09f5-76cc-4fe1-962e-fc7ac41c1342 61 fields · synced May 16, 2026
- EUDAMED 69a55cff-e8c6-4324-b0a2-2576f49ba91c 61 fields · synced May 17, 2026
- EUDAMED 00694118-c46b-4ed7-b140-87d1f0181efa 61 fields · synced May 17, 2026
- EUDAMED 65a5d027-a63a-4cd7-b38f-ec727186c5d7 61 fields · synced May 17, 2026
- EUDAMED 11ac42c9-27a8-4fea-9c02-4c9032a01c8a 61 fields · synced May 17, 2026
- EUDAMED 4263db27-65a1-4bda-9f55-eefe48efe142 61 fields · synced May 17, 2026
- EUDAMED a5743297-c517-4f7b-b478-69936ca0448c 61 fields · synced May 17, 2026
- EUDAMED 1b6155a1-b715-41f5-a384-514e4c9b4a12 61 fields · synced May 17, 2026
- EUDAMED 023037e5-7cdf-47ac-a30d-a20e0428b3e5 61 fields · synced May 17, 2026
- EUDAMED a5a4608e-8260-4011-a09e-1b8c97957666 61 fields · synced May 17, 2026
- EUDAMED 1108c1a6-4f00-4759-94bb-c892c4d34a0f 61 fields · synced May 17, 2026
- EUDAMED e680e975-34d7-4696-9e68-7a3e26012515 61 fields · synced May 17, 2026
- EUDAMED 8b7b2e6e-d1d3-42cb-95d9-0e7b42e19d97 61 fields · synced May 18, 2026
- EUDAMED c34bbb4f-cd1c-42e5-b21b-dbdf6d083902 61 fields · synced May 18, 2026
- EUDAMED f096dcb4-1ce9-4eff-9463-34bb936a7170 61 fields · synced May 18, 2026
- EUDAMED 5d104454-dc0e-4cc3-b5eb-a7fc51a15753 61 fields · synced May 18, 2026
- FDA UDI ed5dfe00-84e7-41d9-8e92-37a91a789f0b 33 fields · synced May 29, 2026
- FDA UDI 736121d8-71b2-4a1f-bb26-3b3b27789eb3 33 fields · synced May 30, 2026
- FDA UDI ea43ca9f-c8d9-430f-a697-898cb70f1c9c 33 fields · synced May 30, 2026
- EUDAMED c955e260-789e-48a1-9dd8-c98515e471e3 61 fields · synced Jul 9, 2026
- EUDAMED 20311c14-40b9-40c1-9d35-4ee8ca53eef4 61 fields · synced Jul 10, 2026
- EUDAMED 7b949ebf-4ce0-442d-985c-bde29266f2a0 61 fields · synced Jul 12, 2026
- EUDAMED 8cafe25d-062f-4e2b-ad39-9349df421336 61 fields · synced Jul 14, 2026
- EUDAMED 85f64c24-66d7-4ee9-8617-869d62e3bcf4 61 fields · synced Jul 18, 2026
- EUDAMED 8fcd1b17-0cfb-455a-bf2e-bd65141c6d17 61 fields · synced Jul 19, 2026
- EUDAMED 8d3b12d0-1c9f-47aa-a6eb-4de6a355577e 61 fields · synced Jul 19, 2026
- EUDAMED dc359f5f-b99e-47b9-b225-d967bf7cc83a 61 fields · synced Jul 26, 2026
- EUDAMED 5f341998-0cea-4ef9-9c0d-db33b4c4e370 61 fields · synced Jul 30, 2026
- EUDAMED 6559b5e1-34e3-4d15-ba05-5d3a058010aa 61 fields · synced Aug 1, 2026
- EUDAMED b1b72ced-463f-4f2b-b285-4f9cf762127d 61 fields · synced Aug 4, 2026
- FDA 510(k) K253075 1 fields · synced Jun 9, 2026