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ES-MF-000001598ARNES DE SUJECION DE TOBILLO ; STRAP FASTENING FOR ANKLE is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Orliman, S.L.U.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 1, 2026
84350259ORL20700Q3Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08435025973718
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 Spain; available across 31 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary 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 |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | 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 |
| XI | — | 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.
08435025973718Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
84350259ORL20700Q31008#EUDI 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.
Y180999CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - OTHERNo 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.84350259ORL20700Q3On the marketARNÉS DE SUJECIÓN CAMA CON IMANES T.2 M: 115-140 ; BED HARNESS WITH MAGNETS BASIC84350259ORL20700Q3On the marketARNÉS DE SUJECIÓN CAMA CON IMANES T.2 M: 115-140 ; HARNESS WITH MAGNETS84350259ORL20700Q3On the marketARNES MUÑECA A CAMA CON IMANES ; HARNESS WRIST FOR BED WITH MAGNETS84350259ORL20700Q3On the marketARNÉS MUÑECA A CINTURÓN IMANES T.UNI ; HARNESS FOR WRIST WITH BELT MAGNETS84350259ORL20700Q3On the marketARNES PARA ABDUCCION PIERNAS T.1 M: 20-28 ; LEG ABDUCTOR HARNESS84350259ORL20700Q3On the marketNo certificate specifically references this device's Basic UDI-DI.