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Zora Explorer
EUDAMEDClass I (EU MDR)
Ref N5909DModel 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 N5909
Identity
- Trade Name
- Zora Explorer EUDAMEDZORA 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 EUDAMEDN5909D 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 EUDAMEDN5909 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978949462705 EUDAMED06970765972475 EUDAMED06978949461586 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
Zora Explorer 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 297fcb02-f1e2-4ef8-b540-c77228f9bc7d 61 fields · synced Jul 22, 2026
- EUDAMED 4e825d46-a408-480e-a3e9-e81233e5cc8d 61 fields · synced May 19, 2026
- EUDAMED 630f7b39-687a-4bf0-87bd-7a0ffc33e3a0 61 fields · synced May 19, 2026