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SOFT, I.-AG pažní náv.s ruk. vel.2D s lemem, tělová
EUDAMEDClass I (EU MDR)
Ref 8591285111946
by MAXIS a.s.
Identity
- Trade Name
- SOFT,I.-AG pažní náv.s ruk. vel.2D s lemem,tělová EUDAMED
- Device Name
- Návleky na horní končetiny MICRO I.KT - Pažní návlek s rukavicí s lemem EUDAMED
- Model / Reference
- 8591285111946 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08591285111946 EUDAMED
- Basic UDI-DI
- 8591285PNRL19M 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
SOFT, I.-AG pažní náv.s ruk. vel.2D s lemem, 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.
- JOBST Relief — BSN MEDICAL, INC. · Class II
- VenoTrain soft — Bauerfeind GmbH & Co. · Class II
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- MEDI — MEDI MANUFACTURING, INC. · Class II
- MEDI — MEDI MANUFACTURING, INC. · Class II
- JOBST Relief — BSN MEDICAL, INC. · Class II
- 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 | 8591285PNRL19M | Class I | Active |
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Manufacturer
- Manufacturer
- MAXIS a.s.
- EUDAMED SRN
- CZ-MF-000000989
Sources (1)
- EUDAMED 1e8c9dbc-6f22-4542-b5be-d4f7f2427ee6 61 fields · synced Jun 18, 2026