Identity
- Trade Name
- PKA311 EUDAMED
- Device Name
- Įtvarinė sistema čiurnos sąnariui EUDAMED
- Model / Reference
- PKA311 EUDAMEDTD/124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04779052761950 EUDAMED
- Basic UDI-DI
- 477905276PKA311HG EUDAMED
- Direct Marketing DI
- 04779052761950 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
Pka311 by UAB Pirmas žingsnis — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 477905276PKA311HG | Class I | Active |
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Manufacturer
- Manufacturer
- UAB Pirmas žingsnis
- EUDAMED SRN
- LT-MF-000004764
Sources (1)
- EUDAMED ecf70df0-7477-49b3-a5b2-d3ca19165789 61 fields · synced Jun 18, 2026