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Acfpc17blk-Eu

EUDAMED

Class I (EU MDR)

Ref W5905AModel 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
ACFPC17BLK-EU 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
W5905A EUDAMED

Identifiers

Primary DI / UDI-DI
06978949461579 EUDAMED
Basic UDI-DI
697894946PW001Y3 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

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Acfpc17blk-Eu 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 6defc15d-6f0e-4a8f-b806-1c1b9aa30d39 61 fields · synced Jul 25, 2026