Identity
- Trade Name
- SAP11 EUDAMED
- Device Name
- Apdukcinė pagalvėlė EUDAMED
- Model / Reference
- SAP11 EUDAMEDTD/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04779052760342 EUDAMED
- Basic UDI-DI
- 477905276SAP11JX EUDAMED
- Direct Marketing DI
- 04779052760342 EUDAMED
- EMDN Code
- M03050299 BANDAGES AND SPLINTS - OTHER 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: Hand/finger splint, reusable
Sap11 by UAB Pirmas žingsnis — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hand/finger splint, reusable.
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- McKie Thumb Splint Pediatric — McKie Splints, LLC · Class I
- Plastalume — BROWNMED, INC. · 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 | 477905276SAP11JX | Class I | Active |
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Manufacturer
- Manufacturer
- UAB Pirmas žingsnis
- EUDAMED SRN
- LT-MF-000004764
Sources (1)
- EUDAMED 4921c764-48be-4648-a56e-0c0a58a19af0 61 fields · synced Jul 12, 2026