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Maramed Posterior Leaf Spring Full Foot Open Heel, Medium, Right
EUDAMEDClass I (EU MDR)
Ref PLS-FFOH-200R
Identity
- Trade Name
- Maramed Posterior Leaf Spring Full Foot Open Heel, Medium, Right EUDAMED
- Device Name
- Maramed Posterior Leaf Spring AFO EUDAMED
- Model / Reference
- PLS-FFOH-200R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810050250887 EUDAMED
- Basic UDI-DI
- 081005025PLS8X EUDAMED
- Direct Marketing DI
- 00810050250887 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
Maramed Posterior Leaf Spring Full Foot Open Heel, Medium, Right by BioSculptor Corporation — 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 | 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 51b69322-0800-40a4-8075-c5fa35044762 61 fields · synced Jun 19, 2026