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BiliSoft Large Pad Nests, Box of 15
EUDAMEDClass I (EU MDR)
Ref 2107201-001Model Disposables Pad Covers and Pad Nests Product Family
Identity
- Device Name
- BiliSoft Large Pad Nests, Box of 15 EUDAMED
- Model / Reference
- Disposables Pad Covers and Pad Nests Product Family EUDAMED2107201-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10812432022522 EUDAMED
- Basic UDI-DI
- 081243202MD078QM EUDAMED
- Unit of Use DI
- 00812432022525 EUDAMED
- EMDN Code
- Z12080499 NEONATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
BiliSoft Large Pad Nests, Box of 15 by Lumitex Medical Devices, Inc. — 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 | 081243202MD078QM | Class I | Active |
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Manufacturer
- Manufacturer
- Lumitex Medical Devices, Inc.
- EUDAMED SRN
- US-MF-000030520
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED f7bd87c0-f8eb-4fd0-ba96-26980dab5105 61 fields · synced Jun 18, 2026