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PL-MF-000007133Round Bolster 15x60 - K515 Black is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by HABYS Sp. z o.o.. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Apr 20, 2026
590781338KszltkiBLPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05907813388811
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 Poland; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Hungary | — | Still on market |
| Netherlands | — | Still on market |
| Romania | — | 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.
05907813388811Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
590781338KszltkiBLT-KSWAK515005EKOUDI 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.
Z120602PHYSIOTHERAPY EQUIPMENT590781338KszltkiBLOn the marketRound Bolster 15x30 K022 Green590781338KszltkiBLOn the marketRound Bolster 15x60 Soft Touch K607 Beige590781338KszltkiBLOn the marketRound Bolster 15x60 - K707 ivory590666749KsztaltkiN9On the marketRound Bolster 15x60 - k722 Gray590666749KsztaltkiN9On the marketRound Bolster 15x60 - k729 Light gray590666749KsztaltkiN9On 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.No certificate specifically references this device's Basic UDI-DI.