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Maramed Posterior Leaf Spring AFO, Large, Left, Complete
EUDAMEDClass I (EU MDR)
Ref PLSC-300LRef PLSC-400L
Identity
- Trade Name
- Maramed Posterior Leaf Spring AFO, Large, Left, Complete EUDAMEDMaramed Posterior Leaf Spring AFO, X-Large, Left, Complete EUDAMED
- Device Name
- Maramed Posterior Leaf Spring AFO EUDAMED
- Model / Reference
- PLSC-300L EUDAMEDPLSC-400L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810050250658 EUDAMED00810050250672 EUDAMED
- Basic UDI-DI
- 081005025PLS8X EUDAMED
- Direct Marketing DI
- 00810050250658 EUDAMED00810050250672 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 Posterior Leaf Spring AFO, Large, Left, Complete 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 (2)
- EUDAMED a32c496e-483f-4807-99bd-fd692d529d1c 61 fields · synced Jul 26, 2026
- EUDAMED 27a1dbc4-9e3b-42b9-83b6-b2a540d47221 61 fields · synced May 17, 2026