Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Custom Monty 3D Swing Away Plus — Class I MDR by Rehadapt GmbH

MD Atlas
Rehadapt GmbH

EUDAMED last updated this device on Jan 20, 2023

Custom Monty 3D Swing Away Plus

++B896WheelchairMountsQB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Rehadapt GmbH
UDI-DI code: +B896113342CM0.
Reference / catalog number: 11.3342CM

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Rehadapt GmbH
SRN: DE-MF-000008141
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: Custom Monty 3D Swing Away Plus
UDI-DI code: +B896113342CM0.
Basic UDI-DI: ++B896WheelchairMountsQB
Reference / catalog number: 11.3342CM
Issuing entity: HIBCC

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Custom M3D wheelchair mount with a RotLok base for extra stability, a swing away joint for easily entering/exiting the wheelchair, and a UDS DC. Max. load capacity: 3.0 kg (6.6 lbs). Tubes and frame clamp not included.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y214299DEVICES FOR INTERPERSONAL COMUNICATION - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

30.3004++B896CAREMOUNTSYSOn the market 30.3001++B896CAREMOUNTSYSOn the market CC AM Box LM150TD++B896CAREMOUNTSYSOn the market CC AM Clip Mount Hook Set black++B896CAREMOUNTSYSOn the market CC AM Clip Mount Hook Set red++B896CAREMOUNTSYSOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.