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Manual wheelchair
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref HM303D、HM302、HM305、HM308、HM306、HM03MS、HM310、HM311、HM312、HM313、HM314、HM315、HM316、HM317、HM318、HM319
Identity
- Device Name
- Manual wheelchair EUDAMED
- Model / Reference
- HM303D、HM302、HM305、HM308、HM306、HM03MS、HM310、HM311、HM312、HM313、HM314、HM315、HM316、HM317、HM318、HM319 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973852590019 EUDAMED
- Basic UDI-DI
- 697385259MwheelchairGV EUDAMED
- Direct Marketing DI
- 06973852590019 EUDAMED
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Manual wheelchair by Kunshan Hi-Fortune Health Products Co., Ltd — 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 | K163352 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697385259MwheelchairGV | Class I | Active |
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Manufacturer
- Manufacturer
- Kunshan Hi-Fortune Health Products Co., Ltd
- EUDAMED SRN
- CN-MF-000035403
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED aa6635a7-eb99-4069-ac69-5ee1f4eb406d 61 fields · synced Oct 7, 2026
- FDA 510(k) K163352 1 fields · synced May 18, 2026