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Jazzy Carbon Max HD
EUDAMEDClass I (EU MDR)
Ref W5915DModel 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 N5919
Identity
- Trade Name
- Jazzy Carbon Max HD EUDAMED
- Device Name
- Power Wheelchair EUDAMED
- Model / Reference
- 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 N5919 EUDAMEDW5915D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970765972604 EUDAMED
- Basic UDI-DI
- 697076597PW001QM 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Jazzy Carbon Max HD 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 | 697076597PW001QM | 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 (1)
- EUDAMED 0a8da995-0141-4a8a-88b3-d44f6958dc58 61 fields · synced Jun 20, 2026