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Omnitex
EUDAMEDClass I (EU MDR)
Ref MK-OX-50RLModel Type IIR Surgical Face Masks
Identity
- Trade Name
- Omnitex EUDAMED
- Device Name
- Type IIR Surgical Face Masks EUDAMED
- Model / Reference
- Type IIR Surgical Face Masks EUDAMEDMK-OX-50RL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060645210337 EUDAMED
- Basic UDI-DI
- 506064521SUFM018U EUDAMED
- Direct Marketing DI
- 05060645210337 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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 | 506064521SUFM018U | 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 7586af18-001d-4e36-bc10-d168a8fd771c 61 fields · synced Jun 19, 2026