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Power scooter
EUDAMEDFDA UDIClass I (EU MDR)
Ref S26Ref PF7SRef S21Ref S20Ref S37.S37+Ref S23Ref S19FRef PF7
Identity
- Trade Name
- Heartway Medical Products Co., Ltd FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Power scooter EUDAMED
- Model / Reference
- S26 EUDAMEDPF7S EUDAMEDS21 EUDAMEDS20 EUDAMEDS37.S37+ EUDAMEDS23 EUDAMEDPF7 EUDAMEDFDA UDIS19F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871230596 EUDAMED04719871233788 EUDAMED04719871232149 EUDAMED04719871232033 EUDAMED04719871230602 EUDAMED04719871233238 EUDAMED04719871230152 EUDAMEDFDA UDI04719871233191 EUDAMED
- Basic UDI-DI
- 471987123PSYV EUDAMED
- Direct Marketing DI
- 04719871230596 EUDAMED04719871233788 EUDAMED04719871232149 EUDAMED04719871232033 EUDAMED04719871230602 EUDAMED04719871233238 EUDAMED04719871233191 EUDAMED04719871230152 EUDAMED
- 510(k) Number
- K080242 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
- Northern Ireland 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
Power scooter by Heartway Medical 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 | 471987123PSYV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Heartway Medical Products Co. Ltd
- EUDAMED SRN
- TW-MF-000003315
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (9)
- EUDAMED 230d660a-e653-4bd4-a237-d4103a7df77d 61 fields · synced Oct 7, 2026
- EUDAMED 08941be0-a0fb-47c3-a69c-b81bb581c57a 61 fields · synced May 11, 2026
- EUDAMED a6587e0a-ac4e-4265-825f-b0a77cc8664a 61 fields · synced May 17, 2026
- EUDAMED 374a7033-0167-4b08-b877-83dd736ddace 61 fields · synced May 17, 2026
- EUDAMED 5953f7f2-1a16-4e36-8a99-561bc1c335d6 61 fields · synced May 17, 2026
- EUDAMED 09fc5006-87dd-4b42-8b2c-8d4790f8ef45 61 fields · synced May 18, 2026
- FDA UDI 815cd30a-08df-43ba-9777-562377d439ae 33 fields · synced May 30, 2026
- EUDAMED 07ba91f9-5ec7-4941-9d7d-03bc3d706a99 61 fields · synced Jul 15, 2026
- EUDAMED 6e34e5d7-b27d-4916-8295-10734c000c90 61 fields · synced Sep 17, 2026