← Back to catalogue
Xlr8
EUDAMEDClass I (EU MDR)
Ref U0890320400399Ref U0900320200399Ref U0900320500399Ref U0890320300399
by Thuasne
Identity
- Device Name
- XLR8 EUDAMED
- Model / Reference
- U0890320400399 EUDAMEDU0900320200399 EUDAMEDU0900320500399 EUDAMEDU0890320300399 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03111790270041 EUDAMED03111790270126 EUDAMED03111790270157 EUDAMED03111790270034 EUDAMED
- Basic UDI-DI
- 311179FR0071DFA EUDAMED
- Direct Marketing DI
- 03111790270041 EUDAMED03111790270126 EUDAMED03111790270157 EUDAMED03111790270034 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Xlr8 by Thuasne — Class I — MDR — listed in 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 (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 | 311179FR0071DFA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thuasne
- EUDAMED SRN
- FR-MF-000001201
Sources (4)
- EUDAMED 4f560039-708a-4719-a56a-a9c6e6e94e7b 61 fields · synced Jul 31, 2026
- EUDAMED bb63c1dc-5eaf-4d66-ac68-ec76cc90d44a 61 fields · synced May 16, 2026
- EUDAMED da5cdbcc-c664-45d8-b3b6-5678b6c59627 61 fields · synced May 17, 2026
- EUDAMED 0b9ff9f8-57fd-4ef8-bb40-0916560ce93f 61 fields · synced May 18, 2026