Identity
- Trade Name
- S38 EUDAMED
- Device Name
- Power Wheelchair EUDAMED
- Model / Reference
- S38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719871234716 EUDAMED
- Basic UDI-DI
- 471987123PWZ5 EUDAMED
- Direct Marketing DI
- 04719871234716 EUDAMED
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
S38 by Heartway Medical Products Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987123PWZ5 | Class I | Active |
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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 (1)
- EUDAMED e0a4ea07-808b-4678-b89f-e2c16b0f7465 61 fields · synced Oct 6, 2026