Identity
- Trade Name
- Maramed Posterior Leaf Spring Full Foot AFO, Medium, Left 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 = Medium, Side = Left FDA UDI
- Model / Reference
- PLS-FF-200L 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 = Medium, Side = Left FDA UDI
Identifiers
- Catalog Number
- PLS-FF-200L FDA UDI
- Primary DI / UDI-DI
- 00810050250795 EUDAMEDFDA UDI
- Basic UDI-DI
- 081005025PLS8X EUDAMED
- Direct Marketing DI
- 00810050250795 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
Similar devices
Also classified as Ankle/foot orthosis.
- Strp Only, Long, SA Wide Fl 12.5 E Stop — Becker Orthopedic Appliance Company · Class I
- Strp, SFL, 8.25in C Stop , AJT, SA, B — Becker Orthopedic Appliance Company · Class I
- Strp, Spl, WF Cal Pl, AJT, SA B, Free Mot LM/RL — Becker Orthopedic Appliance Company · Class I
- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioSculptor Corporation
Sources (2)
- FDA UDI 1d2578d5-bcf8-42fd-b8dd-a36ca008c8b5 35 fields · synced Jul 21, 2026
- EUDAMED 0eab825a-0ad6-419e-880e-6d7ad019cd7b 61 fields · synced Jul 21, 2026