Identity
- Trade Name
- Maramed Sliding AFO, Small, Left EUDAMED
- Device Name
- Maramed Posterior Leaf Spring AFO EUDAMED
- Model / Reference
- PLS-S-100L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810050250931 EUDAMED
- Basic UDI-DI
- 081005025PLS8X EUDAMED
- Direct Marketing DI
- 00810050250931 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Maramed Sliding AFO, Small, Left by BioSculptor Corporation — 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 | 081005025PLS8X | Class I | Active |
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Manufacturer
- Manufacturer
- BioSculptor Corporation
- EUDAMED SRN
- US-MF-000012686
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 5b0c36af-49c7-45a6-a2b4-51510e874c99 61 fields · synced Aug 2, 2026