Organization name

Merrithew International Inc

SRN

CA-MF-000005225

Manufacturer status

Active

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

• Caution

  1.Before getting on the reformer, ensure at least one spring is securely attached to the gearbar. 2.Carriage stopper must be fully inserted at all times when equipment is in use.

• Consult instructions for use

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

• Consult healthcare professional before use

  Before starting an exercise program, consult a physician.

Primary placement in France; available across 28 countries total.

Trade name

Bundle - SPX Max Reformer w/Tall Box

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.

00690650110497

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.

690650REFORMERKA

Reference / catalog number

https://www.merrithew.com/shop/ProductDetail/ST11049_Spx-Max-Reformer-Bundle-With-Tall-Box

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 Pilates reformer is a traditional piece of Pilates equipment which looks like a bed with springs, a sliding carriage, ropes and pulleys. The SPX Max shares the same features and innovations as V2 Max™ Reformers, but is built lower to the ground with a narrower 22 in (56 cm) frame to accommodate multi-use facilities. Expand your programming options with the Reformer Tall box! The extra 4 in (10 cm) height ensures you have the necessary floor clearance to perform the complete Reformer repertoire on the SPX Max!

Additional information URL

https://www.merrithew.com/shop/ProductDetail/ST11049_Spx-Max-Reformer-Bundle-With-Tall-Box

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.