Identity
- Trade Name
- OPERATING ROOM GEL PAD EUDAMED
- Device Name
- Operation Room Gel Positioning Pad EUDAMED
- Model / Reference
- AP416 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809238796196 EUDAMED
- Basic UDI-DI
- 880923879LBT001LM EUDAMED
- Direct Marketing DI
- 08809238796196 EUDAMED
- EMDN Code
- Z12011299 PATIENT POSITIONING INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Operating Room Gel Pad by Libertech Corporation — 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 | 880923879LBT001LM | Class I | Active |
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Manufacturer
- Manufacturer
- Libertech Corporation
- EUDAMED SRN
- KR-MF-000024126
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 5d1ecaa9-c9cf-4875-b8a7-6e0ba7c7cc45 61 fields · synced Jun 18, 2026