Identity
- Trade Name
- SKT514 EUDAMED
- Device Name
- Kelio įtvaras EUDAMED
- Model / Reference
- SKT514 EUDAMEDTD/108 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04779052760649 EUDAMED04779052760656 EUDAMED
- Basic UDI-DI
- 477905276SKT514PC EUDAMED
- Direct Marketing DI
- 04779052760649 EUDAMED04779052760656 EUDAMED
- EMDN Code
- Y061209 KNEE 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
Skt514 by UAB Pirmas žingsnis — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 477905276SKT514PC | Class I | Active |
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Manufacturer
- Manufacturer
- UAB Pirmas žingsnis
- EUDAMED SRN
- LT-MF-000004764
Sources (2)
- EUDAMED 17d9229b-9318-47ee-87b5-f52e22b55ad8 61 fields · synced Jul 17, 2026
- EUDAMED a78a5ac6-2ae9-4a90-9179-8959291f257e 61 fields · synced May 17, 2026