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Omnitex
EUDAMEDClass I (EU MDR)
Ref SIL6090Model Disposable Procedure / Incontinence Bed Pads
Identity
- Trade Name
- Omnitex EUDAMED
- Device Name
- Disposable Procedure / Incontinence Bed Pads EUDAMED
- Model / Reference
- Disposable Procedure / Incontinence Bed Pads EUDAMEDSIL6090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060645213260 EUDAMED
- Basic UDI-DI
- 506064521DISUP01BH EUDAMED
- Direct Marketing DI
- 05060645213260 EUDAMED
- EMDN Code
- T04010201 UNTUCKABLE UNDERPADS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Omnitex by Sharon Services (UK) Ltd. — 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 | 506064521DISUP01BH | Class I | Active |
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Manufacturer
- Manufacturer
- Sharon Services (UK) Ltd.
- EUDAMED SRN
- UK-MF-000047592
- Authorised Representative
- Sharon Services Europe B.V. NL-AR-000047497
Sources (1)
- EUDAMED 2b72c62e-0693-43b3-b7fd-188e3d67cecd 61 fields · synced Jun 18, 2026