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ALFA-Soft Fersenpolster, groß
EUDAMEDClass I (EU MDR)
Ref AL 1700-002
by Semeda GmbH
Identity
- Trade Name
- ALFA-Soft Fersenpolster, groß EUDAMED
- Device Name
- Fersenpolster EUDAMED
- Model / Reference
- AL 1700-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260201550377 EUDAMED
- Basic UDI-DI
- 426020155ZBHFP3X EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES 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
Category: Ankle/foot orthosis
ALFA-Soft Fersenpolster, groß by Semeda GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 426020155ZBHFP3X | Class I | Active |
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Manufacturer
- Manufacturer
- Semeda GmbH
- EUDAMED SRN
- DE-MF-000008334
Sources (1)
- EUDAMED 31e73f82-fac4-47a1-bbd7-17f38ce0e540 61 fields · synced Jun 18, 2026