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mobility scooter
EUDAMEDFDA UDIClass I (EU MDR)
Ref R100Model R100, R100-1, R100-2, R100-3, R100-4, R200, R300, R400, R500, RF01, RF02, RF03
Identity
- Trade Name
- mobility scooter EUDAMEDRayhev FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Mobility Scooter EUDAMED
- Model / Reference
- R100, R100-1, R100-2, R100-3, R100-4, R200, R300, R400, R500, RF01, RF02, RF03 EUDAMEDR100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06976477180016 EUDAMEDFDA UDI
- Basic UDI-DI
- 697647718MS7G EUDAMED
- Direct Marketing DI
- 06976477180016 EUDAMED
- 510(k) Number
- K182411 FDA UDI
- FDA Product Code
- INI FDA UDI
- EMDN Code
- Y122124 ELECTRIC SCOOTERS 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
- Netherlands 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
mobility scooter by Yongkang Ruihe Metal Products Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697647718MS7G | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Yongkang Ruihe Metal Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000036364
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED a31997cd-48d4-42a7-ac52-134853730a8b 61 fields · synced Oct 6, 2026
- FDA UDI 1337a08a-3822-4285-8654-fe4221e8de6e 33 fields · synced May 30, 2026