Organization name

Merrithew International Inc

SRN

CA-MF-000005225

Manufacturer status

Active

3 warnings recorded — scroll inside the panel to see all entries.

• Caution

  Reformer - Before getting on the reformer, ensure at least one spring is securely attached to the gear bar. Carriage stopper must be fully inserted at all times when equipment is in use. Vertical frame - Always attach safety chain when Push-Thru Bar springs are engaged from below. Ensure all spring clips are fully closed. Grip securely when using Push-Thru Bar. Use only under supervision.

• Consult healthcare professional before use

  Before starting an exercise program, consult a physician.

• Consult instructions for use

  Before using the equipment, read and follow instructions in the IFU and obtain thorough instruction from a qualified trainer.

Primary placement in France; available across 28 countries total.

Trade name

Bundle - V2 Max Plus (Black Ropes)

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.

00690650111289

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.

690650REFORMERVERTFRAMEYZ

Reference / catalog number

ST-11128

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.

GS1

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

The “Cadillac” of our Reformer line, the V2 Max Plus™ Reformer facilitates limitless exercise possibilities. This one-of-a-kind unit multitasks as a raised Mat platform, a Reformer, a virtual Cadillac and a breakthrough multi-planar, biomechanics training tool. Equipped with our innovative retractable rope system and travelling pulleys on the vertical frame, the V2 Max Plus offers variable angles of resistance, providing an increased range of motion, making it the premier tool for Pilates-based sport-specific, rehab and cross-training movement. Includes the Mat Converter, Reformer Box with footstrap, Padded Platform Extender and Maple Roll-Up Pole

Additional information URL

https://www.merrithew.com/get-started

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.

• Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER

• Class I medical devices in EUDAMED

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