Monty 3D Curved L

Organization name

Rehadapt GmbH

SRN

DE-MF-000008141

Manufacturer status

Active

+B89611631203

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.

Primary placement in Germany; available across 14 countries total.

Trade name

Monty 3D Curved L

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

+B89611631203

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

++B896WheelchairMountsQB

Reference / catalog number

11.6312

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

HIBCC

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

M3D two-tube wheelchair mount with curved tube. RotLok base with swivel function and UDS-DC. Dimensions (height x offset x tube 2): 760 x 300 x 400 mm (30 x 12 x 16"). Max. load capacity: 3.0 kg (6.6 lbs). Frame clamp not included.

Additional information URL

https://rehadapt.com/11.6312

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y214299DEVICES FOR INTERPERSONAL COMUNICATION - OTHER

• Class I medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.