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CA-MF-000005225Bundle - One-on-One Studio (Jet Black) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Merrithew International Inc. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 22, 2026
690650REFORMERVERTFRAMEYZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00690650111159
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
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.
Before starting an exercise program, consult a physician.
Before using the equipment, read and follow instructions in the IFU and obtain thorough instruction from a qualified trainer.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in France; available across 28 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00690650111159Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
690650REFORMERVERTFRAMEYZST-11115UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHERNo certificate specifically references this device's Basic UDI-DI.
690650REFVFRAMECHAIRCADW2On the marketBundle - Complete Studio (SPX Max)690650REFSCHAIRCADTRTABL5On the marketBundle - Core One-on-One Studio690650REFORMERKAOn the marketBundle - One-On-One Studio Starter 1690650REFVFRAMESCHAIR59On the marketBundle - One-On-One Studio Starter 2ST-11001690650REFVFRAMECHAIRCADW2On the marketBundle - Pilates Rehab Enhanced One-On-One Studio690650REFVFRAMECHAIRCADW2On the marketNo 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.