Identity
- Trade Name
- ALFA-Flex Sohlenplatten EUDAMED
- Device Name
- Sohlenplatten EUDAMED
- Model / Reference
- ET 0700-003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260201551046 EUDAMED
- Basic UDI-DI
- 426020155ZBHSPL5T EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER 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
ALFA-Flex Sohlenplatten 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 | 426020155ZBHSPL5T | Class I | Active |
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Manufacturer
- Manufacturer
- Semeda GmbH
- EUDAMED SRN
- DE-MF-000008334
Sources (1)
- EUDAMED 6a5c917e-3e9c-4918-a280-8f5cd931c8d2 61 fields · synced Jul 11, 2026