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WHILL Model R
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 32-21014-1-03-2025-02-28510(k) K242760
by WHILL, Inc.
Identity
- Device Name
- WHILL Model R EUDAMED
- Model / Reference
- 32-21014-1-03-2025-02-28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04570072305137 EUDAMED
- Basic UDI-DI
- 457007230PWDScooterH7 EUDAMED
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
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
WHILL Model R by Whill, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K242760 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 457007230PWDScooterH7 | Class I | Active |
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Manufacturer
- Manufacturer
- WHILL, Inc.
- EUDAMED SRN
- JP-MF-000016481
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 7082731a-6000-4600-86d4-755d70463373 85 fields · synced Jun 18, 2026
- FDA 510(k) K242760 1 fields · synced May 18, 2026