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Omnitex
EUDAMEDClass I (EU MDR)
Ref OX-BACL26Model Wash Cloths / Wipes with Barrier CreamRef OX-THEL-100BLModel Disposable Theatre CapsRef NTWP8590Model Bed Pads washableRef PKWP9090Ref DIA6090Model Disposable Procedure / Incontinence Bed PadsRef OX-BIB100-ADModel Disposable Bibs / clothing protectorsRef SIL4060Ref OX-WGB10Model Non Woven Wash Gloves with Barrier CreamRef MK-OX-50TBModel Type IIR Surgical Face MasksRef MK-OX-50DURef OX-THTS-100GR
Identity
- Trade Name
- Omnitex EUDAMED
- Device Name
- Wash Cloths / Wipes with Barrier Cream EUDAMEDDisposable Theatre Caps EUDAMEDBed Pads washable EUDAMEDDisposable Procedure / Incontinence Bed Pads EUDAMEDDisposable Bibs / clothing protectors EUDAMEDNon Woven Wash Gloves with Barrier Cream EUDAMEDType IIR Surgical Face Masks EUDAMED
- Model / Reference
- Wash Cloths / Wipes with Barrier Cream EUDAMEDOX-BACL26 EUDAMEDDisposable Theatre Caps EUDAMEDOX-THEL-100BL EUDAMEDBed Pads washable EUDAMEDNTWP8590 EUDAMEDPKWP9090 EUDAMEDDisposable Procedure / Incontinence Bed Pads EUDAMEDDIA6090 EUDAMEDDisposable Bibs / clothing protectors EUDAMEDOX-BIB100-AD EUDAMEDSIL4060 EUDAMEDNon Woven Wash Gloves with Barrier Cream EUDAMEDOX-WGB10 EUDAMEDType IIR Surgical Face Masks EUDAMEDMK-OX-50TB EUDAMEDMK-OX-50DU EUDAMEDOX-THTS-100GR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060645211723 EUDAMED05060645214748 EUDAMED05060645210443 EUDAMED05060645213994 EUDAMED05060645212645 EUDAMED05060645212614 EUDAMED05060645212621 EUDAMED05060645211624 EUDAMED05060645210528 EUDAMED05060645211068 EUDAMED05060645214731 EUDAMED
- Basic UDI-DI
- 506064521BWC01XZ EUDAMED506064521THCAP019Q EUDAMED506064521RESBP01D6 EUDAMED506064521DISUP01BH EUDAMED506064521BIB01US EUDAMED506064521BWG01YM EUDAMED506064521SUFM018U EUDAMED
- Direct Marketing DI
- 05060645211723 EUDAMED05060645214748 EUDAMED05060645210443 EUDAMED05060645213994 EUDAMED05060645212645 EUDAMED05060645212614 EUDAMED05060645212621 EUDAMED05060645211624 EUDAMED05060645210528 EUDAMED05060645211068 EUDAMED05060645214731 EUDAMED
- EMDN Code
- T0499 INCONTINENCE DEVICES - OTHER EUDAMEDT0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMEDT04010299 ABSORBENT UNDERPADS - OTHER EUDAMEDT04010201 UNTUCKABLE UNDERPADS EUDAMEDT99 PROTECTIVE DEVICES AND AIDS FOR INCONTINENCE (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMEDT020604 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 | 506064521BWC01XZ | 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 (11)
- EUDAMED 1aab1344-b87d-4153-992b-457af3150dc9 61 fields · synced Aug 2, 2026
- EUDAMED e3fc5ca3-a103-49b8-9ede-e6d84567e47b 61 fields · synced May 17, 2026
- EUDAMED b0620f6c-70dc-4d60-b5e9-0e9939b67641 61 fields · synced May 18, 2026
- EUDAMED 7ab7a2e8-f5ed-4976-bf52-0d8181160ae9 61 fields · synced May 18, 2026
- EUDAMED 76688f54-faae-40c8-93b2-4bd5eabd8126 61 fields · synced May 18, 2026
- EUDAMED f9aced32-2e89-4184-aa9e-d09ada0661e2 61 fields · synced May 18, 2026
- EUDAMED 032710fc-abf8-4917-9e40-f147496c69e5 61 fields · synced May 18, 2026
- EUDAMED 54f04421-0775-4748-b424-3a6a811bd77e 61 fields · synced May 18, 2026
- EUDAMED 6b12d0e5-c969-486c-a1c8-d6bd02fdcb59 61 fields · synced May 19, 2026
- EUDAMED cbe6ba99-3474-427d-b17d-3e5901323f98 61 fields · synced May 19, 2026
- EUDAMED 4ac2993c-1cba-47fa-95fc-61b1102b9d95 61 fields · synced May 19, 2026