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Rollator

EUDAMEDFDA UDI

Class I (EU MDR)

Ref Y120606Model LCMR002

by Changzhou Langcheng Intelligent Technology Co. , Ltd.

Identity

Trade Name
Rollator EUDAMED
LCJ FDA UDI
Generic Name
Walking chair, foldable FDA UDI
Device Name
Rollator EUDAMED
Model / Reference
LCMR002 EUDAMEDFDA UDI
Y120606 EUDAMED

Identifiers

Primary DI / UDI-DI
06975372290004 EUDAMEDFDA UDI
Basic UDI-DI
697537229LCMR002VW EUDAMED
Direct Marketing DI
06975372290004 EUDAMED
FDA Product Code
ITJ FDA UDI
EMDN Code
Y120606 WHEELED WALKER EUDAMED
GMDN Term
Walking chair, foldable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
890.3825 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Walking chair, non-foldable

Rollator by Changzhou Langcheng Intelligent Technology Co. , Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Walking chair, non-foldable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

EUDAMED SRN
CN-MF-000028091
Authorised Representative
Kingsmead Service B.V. NL-AR-000002066

Sources (2)

  • EUDAMED abc1b6e2-25ee-4422-8bf8-6d0ba4ed8f29 61 fields · synced Jun 19, 2026
  • FDA UDI 53a8c5b2-27ff-4367-baa6-4444cd538c1c 32 fields · synced May 30, 2026