No Certificate Found

Snapshot 2026-10-13 · Link to EUDAMED

Dorsal Night Splint

UDI-DI 04719964465010Basic UDI-DI 47199644662WL

Class I · MDR · Orthotech Rehabilitation Co., Ltd.

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Identification

Model: AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016
EMDN: Y06120601
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-13 · Link to EUDAMED

Manufacturer

Orthotech Rehabilitation Co., Ltd.

SRN CN-MF-000051924

CN · Xiamen

manufacturer

Authorised representative: SUNGO Europe B.V. (NL-AR-000000247)

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AFO Leaf Spring 04719964460398
AFO Leaf Spring 04719964460343
AFO Leaf Spring 04719964460381
AFO Splint 04719964460251
AFO Splint 04719964460299
AFO Splint 04719964460275
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Showing 12 of 98 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/dorsal-night-splint-5010 · UDI page: /udi/04719964465010

All devices from Orthotech Rehabilitation Co., Ltd.

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