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manual wheelchair
EUDAMEDClass I (EU MDR)
Ref GCSW-9007Model GCSW-9000Ref GCSW-9013Ref GCSW-9003Ref GCSW-9017Ref GCSW-9001Ref GCSW-9015Ref GCSW-9002Ref GCSW-9018Ref GCSW-9011Ref GCSW-9010
Identity
- Device Name
- manual wheelchair EUDAMED
- Model / Reference
- GCSW-9000 EUDAMEDGCSW-9007 EUDAMEDGCSW-9013 EUDAMEDGCSW-9003 EUDAMEDGCSW-9017 EUDAMEDGCSW-9001 EUDAMEDGCSW-9015 EUDAMEDGCSW-9002 EUDAMEDGCSW-9018 EUDAMEDGCSW-9011 EUDAMEDGCSW-9010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977812260578 EUDAMED06977812260639 EUDAMED06977812260530 EUDAMED06977812260677 EUDAMED06977812260516 EUDAMED06977812260653 EUDAMED06977812260523 EUDAMED06977812260684 EUDAMED06977812260615 EUDAMED06977812260608 EUDAMED
- Basic UDI-DI
- 697781226GCSW001X4 EUDAMED
- EMDN Code
- Y122103 PUSH WHEELCHAIRS 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
manual wheelchair by Guanchi Technology (Hebei) 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 | 697781226GCSW001X4 | Class I | Active |
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Manufacturer
- Manufacturer
- Guanchi Technology (Hebei) Co., Ltd.
- EUDAMED SRN
- CN-MF-000044147
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (10)
- EUDAMED 7b331903-f13a-461e-9d72-d43a085b8cd6 61 fields · synced Aug 2, 2026
- EUDAMED a1a1d901-1505-45ce-8ec2-103069ea5c04 61 fields · synced May 17, 2026
- EUDAMED 652f3213-19bf-45fc-a141-287d1e2702b8 61 fields · synced May 17, 2026
- EUDAMED 946ea2db-b4fe-4c76-9fae-b671fb191142 61 fields · synced May 17, 2026
- EUDAMED e8081055-ee29-48ae-89bf-ec16365b2d01 61 fields · synced May 17, 2026
- EUDAMED 3ff0cd52-f14d-4406-b984-84815af9cbc2 61 fields · synced May 18, 2026
- EUDAMED 918f8d2c-3f13-4fde-92fb-35c294163eeb 61 fields · synced May 18, 2026
- EUDAMED 5a6f804a-982e-4e78-85bc-c34d7f97b618 61 fields · synced May 18, 2026
- EUDAMED 75ef8d17-ff44-4825-8bbf-fb6514e1e37a 61 fields · synced May 19, 2026
- EUDAMED a2d348cb-e86a-4153-8110-b6fc43451cac 61 fields · synced May 19, 2026