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Igo Power Wheelchair

EUDAMED

Class I (EU MDR)

Ref N5513AModel 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

by Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

Identity

Trade Name
IGO POWER WHEELCHAIR 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 EUDAMED
N5513A EUDAMED

Identifiers

Primary DI / UDI-DI
06978949460992 EUDAMED
Basic UDI-DI
697894946PW001Y3 EUDAMED
EMDN Code
Y122127 ELECTRIC 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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Igo Power Wheelchair 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

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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 cb4b0f01-c2e1-462b-a0b7-5ac5544d2276 61 fields · synced Aug 3, 2026