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US-MF-000045340Studio Reformer® Infinity is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Balanced Body Inc. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 24, 2025
0810052148000LSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00810052140421
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.
Refrain from performing or teaching exercises in a high kneeling or standing position in a group setting. Perform the exercises only under the close supervision of a qualified Pilates instructor who can intervene to prevent a fall if the user loses balance.
Before using the Reformer read and follow the Instructions for use (IFU). Use under the supervision of a Pilates Instructor specifically certified to train on the use of the Reformer.
Consult your healthcare professional before starting an exercise program.
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 Germany; available across 29 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jul 14, 2005 | Dec 31, 2099 |
| Austria | Jul 14, 2005 | Dec 31, 2099 |
| Belgium | Jul 14, 2005 | Dec 31, 2099 |
| Bulgaria | Jul 14, 2005 | Dec 31, 2099 |
| Cyprus | Jul 14, 2005 | Dec 31, 2099 |
| Czechia | Jul 14, 2005 | Dec 31, 2099 |
| Denmark | Jul 14, 2005 | Dec 31, 2099 |
| Estonia | Jul 14, 2005 | Dec 31, 2099 |
| EL | Jul 14, 2005 | Dec 31, 2099 |
| Spain | Jul 14, 2005 | Dec 31, 2099 |
| Finland | Jul 14, 2005 | Dec 31, 2099 |
| France | Jul 14, 2005 | Dec 31, 2099 |
| Croatia | Jul 14, 2005 | Dec 31, 2099 |
| Hungary | Jul 14, 2005 | Dec 31, 2099 |
| Ireland | Jul 14, 2005 | Dec 31, 2099 |
| Italy | Jul 14, 2005 | Dec 31, 2099 |
| Lithuania | Jul 14, 2005 | Dec 31, 2099 |
| Luxembourg | Jul 14, 2005 | Dec 31, 2099 |
| Latvia | Jul 14, 2005 | Dec 31, 2099 |
| Malta | Jul 14, 2005 | Dec 31, 2099 |
| Netherlands | Jul 14, 2005 | Dec 31, 2099 |
| Norway | Jul 14, 2005 | Dec 31, 2099 |
| Poland | Jul 14, 2005 | Dec 31, 2099 |
| Portugal | Jul 14, 2005 | Dec 31, 2099 |
| Romania | Jul 14, 2005 | Dec 31, 2099 |
| Sweden | Jul 14, 2005 | Dec 31, 2099 |
| Slovenia | Jul 14, 2005 | Dec 31, 2099 |
| Slovakia | Jul 14, 2005 | Dec 31, 2099 |
| XI | Jul 14, 2005 | Dec 31, 2099 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00810052140421Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0810052148000LS12000CUDI 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.
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.0810052148000LSOn the marketStudio Reformer® 18 inch0810052148000LSOn the marketStudio Reformer® 18 inch, Revo Footbar with Tower0810052148000LSOn the marketStudio Reformer® Revo 140810052148000LSOn the marketStudio Reformer® Revo Footbar0810052148000LSOn the marketStudio Reformer® Revo Footbar with Tower0810052148000LSOn the market