Identity
- Trade Name
- SOFT FLEX EUDAMED
- Device Name
- Mattress EUDAMED
- Model / Reference
- SOFT-FLEX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 85942023200252 EUDAMED
- Basic UDI-DI
- 859420232M01KD EUDAMED
- Direct Marketing DI
- 85942023200252 EUDAMED
- EMDN Code
- V080702 NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES 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
Soft Flex by PROMA REHA, s.r.o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 859420232M01KD | Class I | Active |
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Manufacturer
- Manufacturer
- PROMA REHA, s.r.o.
- EUDAMED SRN
- CZ-MF-000013860
Sources (1)
- EUDAMED c919d428-882e-46d8-86c0-a7dfd3270165 61 fields · synced Jul 21, 2026