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PL-MF-000007130Compress Flex Sanity Medium (19 x 22 cm) is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Albert Polska 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 Mar 12, 2026
59074389104UUPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05907438902843
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
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 5 countries total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | May 26, 2021 | Still on market |
| Germany | May 26, 2021 | Still on market |
| Spain | May 26, 2021 | Still on market |
| Croatia | May 26, 2021 | Still on market |
| Romania | May 26, 2021 | 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.
05907438902843Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
59074389104UU0000000001206UDI 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.
1 packaging level registered — each level carries its own UDI-DI.
05907438902843× 1 unitBase unit15907438902840× 6 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
M9001CRYOTHERAPY AND THERMOTHERAPY DEVICESNo certificate specifically references this device's Basic UDI-DI.
59074389102UQOn the marketBulb syringe Sanity no 959074389103USOn the marketCompress Flex Sanity Max (19 x 30 cm)59074389104UUOn the marketCompress Flex Sanity Mini (10 x10 cm)59074389104UUOn the marketCompress Flex Sanity Standard (10 x 26 cm)59074389104UUOn the marketGruszka Sanity z kanką59074389103USOn 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.