Identity
- Trade Name
- Cytolax EUDAMED
- Device Name
- Non-Sterile Ultrasound Gel EUDAMED
- Model / Reference
- Non-Sterile Ultrasound Gel EUDAMEDUSGEL-250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060645212201 EUDAMED
- Basic UDI-DI
- 506064521NSUSG01KQ EUDAMED
- Direct Marketing DI
- 05060645212201 EUDAMED
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES 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
Cytolax 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 | 506064521NSUSG01KQ | 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 252f75bc-cb0e-4bcd-8221-700cb01ef764 61 fields · synced Jun 17, 2026