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TOBILLERA NEOPRENO C/ CREMALLERA - Tobillera Neopreno C/ Cremallera
EUDAMEDClass I (EU MDR)
Ref 4403#5
Identity
- Trade Name
- TOBILLERA NEOPRENO C/ CREMALLERA ; ANKLE SUPPORT W/ ZIP FASTENER EUDAMED
- Device Name
- Tobilleras elásticas EUDAMED
- Model / Reference
- 4403#5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435025907225 EUDAMED
- Basic UDI-DI
- 84350259ORL20405PW EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
- Models / Variants
- Tobillera Neopreno C/ Cremallera EUDAMEDAnkle Support W/ Zip Fastener EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
TOBILLERA NEOPRENO C/ CREMALLERA - Tobillera Neopreno C/ Cremallera by Orliman, S.L.U. — Class I — MDR — listed in EUDAMED — 2 models
Similar devices
Also classified as Ankle/foot orthosis.
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- 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 (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 | 84350259ORL20405PW | Class I | Active |
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Manufacturer
- Manufacturer
- Orliman, S.L.U.
- EUDAMED SRN
- ES-MF-000001598
Sources (1)
- EUDAMED f5670526-201d-4b01-8926-8e5eb2b4636c 61 fields · synced Oct 6, 2026