- Role
- Country
- Date of registration
- Address
PL-MF-000032129FOOT MORNING - AIRY - wkładki ortopedyczne dla osób dorosłych z podparciem sklepienia podłużnego stopy i pelotą metatarsalną, r.38 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by "KAPS" SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 1, 2026
59082269wkladkiAIRY6NPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05907481122625
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.
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OTHER
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 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | 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.
05907481122625Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
59082269wkladkiAIRY6N103_5004UDI 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.
Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)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.59082269wklaSTABILEKIDSW8On the marketFOOT MORNING - AIRY - wkładki ortopedyczne dla osób dorosłych z podparciem sklepienia podłużnego stopy i pelotą metatarsalną, r.3659082269wkladkiAIRY6NOn the marketFOOT MORNING - AIRY - wkładki ortopedyczne dla osób dorosłych z podparciem sklepienia podłużnego stopy i pelotą metatarsalną, r.3759082269wkladkiAIRY6NOn the marketFOOT MORNING - AIRY - wkładki ortopedyczne dla osób dorosłych z podparciem sklepienia podłużnego stopy i pelotą metatarsalną, r.3959082269wkladkiAIRY6NOn the marketFOOT MORNING - AIRY - wkładki ortopedyczne dla osób dorosłych z podparciem sklepienia podłużnego stopy i pelotą metatarsalną, r.4059082269wkladkiAIRY6NOn the marketFOOT MORNING - AIRY - wkładki ortopedyczne dla osób dorosłych z podparciem sklepienia podłużnego stopy i pelotą metatarsalną, r.4159082269wkladkiAIRY6NOn the marketNo certificate specifically references this device's Basic UDI-DI.