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Jazzy Carbon
EUDAMEDClass I (EU MDR)
Ref N5515AModel N5513,N5513A,N5515,N5515A,N5516,N5516A, N5516C,W5517,N5517A,N5519,W5521,W5521B, N5525,W5526,W5536,W5536A,W5536B,W5538, W5538D,N5901,W5905,W5905A,W5907, Q50 R Carbon,N5909,N5909A,W5211,W5211B, W5213,W5213C,W5216,W5217,N5909D,W5915B, W5915C,W5915D,N5919Model N5513 N5513A N5515 N5515A N5516 N5516A W5517 N5517A N5519 W5521 W5521B N5525 W5526 W5536 W5536A W5536B W5538 N5901 W5905 W5905A W5907 Q50 R Carbon N5909 N5909A W5211 W5211B W5213 W5213C W5216 W5217 N5909D W5915B W5915D N5919Ref W5915B
Identity
- Trade Name
- Jazzy Carbon EUDAMEDJazzy Carbon Max EUDAMED
- Device Name
- Power Wheelchair EUDAMED
- Model / Reference
- N5513,N5513A,N5515,N5515A,N5516,N5516A, N5516C,W5517,N5517A,N5519,W5521,W5521B, N5525,W5526,W5536,W5536A,W5536B,W5538, W5538D,N5901,W5905,W5905A,W5907, Q50 R Carbon,N5909,N5909A,W5211,W5211B, W5213,W5213C,W5216,W5217,N5909D,W5915B, W5915C,W5915D,N5919 EUDAMEDN5515A EUDAMEDN5513 N5513A N5515 N5515A N5516 N5516A W5517 N5517A N5519 W5521 W5521B N5525 W5526 W5536 W5536A W5536B W5538 N5901 W5905 W5905A W5907 Q50 R Carbon N5909 N5909A W5211 W5211B W5213 W5213C W5216 W5217 N5909D W5915B W5915D N5919 EUDAMEDW5915B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978949462446 EUDAMED06970765972444 EUDAMED06970765972574 EUDAMED
- Basic UDI-DI
- 697894946PW001Y3 EUDAMED697076597PW001QM EUDAMED
- EMDN Code
- Y122127 ELECTRIC 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
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Jazzy Carbon by Zhejiang Innuovo Rehabilitation Devices 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 | 697894946PW001Y3 | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000008727
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 62c9f6af-7dac-427c-909f-4b3288a10786 61 fields · synced Jul 9, 2026
- EUDAMED d211a9ba-8c7e-4297-85ab-f52be201bfb7 61 fields · synced May 19, 2026
- EUDAMED a03ab1e5-5344-4f67-a20d-4263859b6f3e 61 fields · synced May 19, 2026