Identity
- Trade Name
- SAP12 EUDAMED
- Device Name
- Universali apdukcinė pagalvėlė EUDAMED
- Model / Reference
- SAP12 EUDAMEDTD/99 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04779052760380 EUDAMED04779052760366 EUDAMED
- Basic UDI-DI
- 477905276SAP12JZ EUDAMED
- Direct Marketing DI
- 04779052760380 EUDAMED04779052760366 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
Sap12 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 | 477905276SAP12JZ | Class I | Active |
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Manufacturer
- Manufacturer
- UAB Pirmas žingsnis
- EUDAMED SRN
- LT-MF-000004764
Sources (2)
- EUDAMED 2975de83-58de-4483-bafa-6bbc76c97d24 61 fields · synced Jul 30, 2026
- EUDAMED 12e2656a-38c8-4277-831d-1331fb557e0b 61 fields · synced May 19, 2026