1191890037050

EUDAMED

Class I (EU MDR)

Ref HCT-9189 BlueModel HCT-9166A,HCT-9166B,HCT-9266A,HCT-9102B,HCT-9102D,HCT-9189,HCT-9102E,HCT-9226S,HCT-9137,HCT-9137A,HCT-9124,HCT-9124A,HCT-9188,HCT-9188B,HCT-9123,HCT-9210A,HCT-9210C,HCT-9201A,HCT-9201B,HCT-9201C,HCT-9201E,HCT-9291,HCT-9291B,HCT-9291C,HCT-9291D,...etc

by Foshan HCT Medical Equipment Co., ltd

Identity

Trade Name: 1191890037050 EUDAMED
Device Name: rollator EUDAMED
Model / Reference: HCT-9166A,HCT-9166B,HCT-9266A,HCT-9102B,HCT-9102D,HCT-9189,HCT-9102E,HCT-9226S,HCT-9137,HCT-9137A,HCT-9124,HCT-9124A,HCT-9188,HCT-9188B,HCT-9123,HCT-9210A,HCT-9210C,HCT-9201A,HCT-9201B,HCT-9201C,HCT-9201E,HCT-9291,HCT-9291B,HCT-9291C,HCT-9291D,...etc EUDAMED
HCT-9189 Blue EUDAMED

Identifiers

Primary DI / UDI-DI: 06973536540361 EUDAMED
Basic UDI-DI: 697353654rollator001XL EUDAMED
EMDN Code: Y120612 WALKING TROLLEYS EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

1191890037050 by Foshan HCT Medical Equipment 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	697353654rollator001XL	Class I	Active

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Manufacturer

Manufacturer: Foshan HCT Medical Equipment Co., ltd
EUDAMED SRN: CN-MF-000022837
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (1)

EUDAMED 47132a40-a9c0-4017-845f-b9cabcc85dec 61 fields · synced Oct 9, 2026