Identity
- Trade Name
- BETA-Flex Schutzpolster EUDAMED
- Device Name
- Schienen Schutzpolster EUDAMED
- Model / Reference
- BE 0600-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260201550384 EUDAMED
- Basic UDI-DI
- 426020155ZBHSP56 EUDAMED
- EMDN Code
- Y061280 LOWER LIMB ORTHOSES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
BETA-Flex Schutzpolster by Semeda GmbH — 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 | 426020155ZBHSP56 | Class I | Active |
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Manufacturer
- Manufacturer
- Semeda GmbH
- EUDAMED SRN
- DE-MF-000008334
Sources (1)
- EUDAMED 8c839ecd-db56-403b-82b8-913a0e62a8ce 61 fields · synced Jun 18, 2026