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Kompres Flex Sanity Mini (10 x10 cm)
EUDAMEDClass I (EU MDR)
Ref 0000000000839Model Mini (10 x10 cm), Standard (10 x 26 cm), Medium (19 x 22 cm), Max (19 x 30 cm)
Identity
- Trade Name
- Kompres Flex Sanity Mini (10 x10 cm) EUDAMED
- Device Name
- Kompres Flex Sanity EUDAMED
- Model / Reference
- Mini (10 x10 cm), Standard (10 x 26 cm), Medium (19 x 22 cm), Max (19 x 30 cm) EUDAMED0000000000839 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907438902089 EUDAMED
- Basic UDI-DI
- 59074389104UU EUDAMED
- Direct Marketing DI
- 05907438902089 EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hot/cold therapy pack, reusable
Kompres Flex Sanity Mini (10 x10 cm) by Albert Polska Sp. z o.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 59074389104UU | Class I | Active |
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Manufacturer
- Manufacturer
- Albert Polska Sp. z o.o.
- EUDAMED SRN
- PL-MF-000007130
Sources (1)
- EUDAMED cfcbc719-a103-4768-8776-91396ea1ea06 61 fields · synced Jun 19, 2026