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Omnitex
EUDAMEDClass I (EU MDR)
Ref OX-GRE10Model Non Woven Wash Gloves with Barrier Cream
Identity
- Trade Name
- Omnitex EUDAMED
- Device Name
- Non Woven Wash Gloves with Barrier Cream EUDAMED
- Model / Reference
- Non Woven Wash Gloves with Barrier Cream EUDAMEDOX-GRE10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060645212300 EUDAMED
- Basic UDI-DI
- 506064521BWG01YM EUDAMED
- Direct Marketing DI
- 05060645212300 EUDAMED
- EMDN Code
- T0499 INCONTINENCE DEVICES - OTHER 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 | 506064521BWG01YM | 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 41e17783-89c6-4c64-b99b-4328ede552c9 61 fields · synced Jun 19, 2026