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I., PROMAX, AG, 8N protiskluz.lem, tělová
EUDAMEDClass I (EU MDR)
Ref 8591285280147Ref 8591285280789
by MAXIS a.s.
Identity
- Trade Name
- I.,PROMAX,AG,8N protiskluz.lem,tělová EUDAMEDI.,S,PROMAX,AG,8N protiskluz.lem,tělová EUDAMED
- Device Name
- Kompresní punčochy PROMAX Standard I.KT - Stehenní punčocha s neklouzavým zakončením EUDAMED
- Model / Reference
- 8591285280147 EUDAMED8591285280789 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591285280147 EUDAMED08591285280789 EUDAMED
- Basic UDI-DI
- 8591285AGLP12D EUDAMED
- EMDN Code
- M030405 COMPRESSION STOCKINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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: Compression/pressure sock/stocking, single-use
I., PROMAX, AG, 8N protiskluz.lem, tělová by MAXIS a.s. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Compression/pressure sock/stocking, single-use.
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- MEDI — MEDI MANUFACTURING, INC. · Class II
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- VenoTrain micro — Bauerfeind GmbH & Co. · Class II
- VenoTrain soft, AG, Top band silicone micro dots, Ccl2, open toe, L Plus short, Cream — Bauerfeind AG · Class I
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 | 8591285AGLP12D | Class I | Active |
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Manufacturer
- Manufacturer
- MAXIS a.s.
- EUDAMED SRN
- CZ-MF-000000989
Sources (2)
- EUDAMED 45d5c832-9036-498c-8fd1-c07cb62c2dec 61 fields · synced Oct 6, 2026
- EUDAMED 9c6f0359-33be-4bc5-9eb9-7b61c6abbefe 61 fields · synced May 19, 2026