Identity
- Trade Name
- Maramed Posterior Leaf Spring Full Foot AFO, Small, Right EUDAMEDMaramed Orthopedic Systems FDA UDI
- Generic Name
- Ankle/foot orthosis FDA UDI
- Device Name
- Maramed Posterior Leaf Spring AFO EUDAMEDThe ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are fabricated in a predorsiflexed position to provide superior dorsiflexion assist. Size = Small, Side = Right FDA UDI
- Model / Reference
- PLS-FF-100R EUDAMEDFDA UDI
- Description
- The ankle foot orthoses/drop foot splints provide a full foot section for additional support and comfort when indicated and are fabricated in a predorsiflexed position to provide superior dorsiflexion assist. Size = Small, Side = Right FDA UDI
Identifiers
- Catalog Number
- PLS-FF-100R FDA UDI
- Primary DI / UDI-DI
- 00810050250788 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005025PLS8X EUDAMED
- Direct Marketing DI
- 00810050250788 EUDAMED
- FDA Product Code
- OHI FDA UDI
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
- GMDN Term
- Ankle/foot orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3475 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ankle/foot orthosis
Maramed Orthopedic Systems by BioSculptor Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- BioSculptor Corporation
Sources (2)
- FDA UDI 34b52719-2938-4d93-b8e0-cfe1c83ee074 35 fields · synced Jun 19, 2026
- EUDAMED ed36e1bc-2f5f-456b-ab3a-e999cd195e95 61 fields · synced Jun 19, 2026