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Cytolax
EUDAMEDClass I (EU MDR)
Ref USGEL-5LModel Non-Sterile Ultrasound GelRef USGEL-20Ref CY-BAC-TSModel Barrier Cream formulation to protect skinRef CY-BAC120Ref CY-NSPY50Model Barrier film Spray
Identity
- Trade Name
- Cytolax EUDAMED
- Device Name
- Non-Sterile Ultrasound Gel EUDAMEDBarrier Cream formulation to protect skin EUDAMEDBarrier film Spray EUDAMED
- Model / Reference
- Non-Sterile Ultrasound Gel EUDAMEDUSGEL-5L EUDAMEDUSGEL-20 EUDAMEDBarrier Cream formulation to protect skin EUDAMEDCY-BAC-TS EUDAMEDCY-BAC120 EUDAMEDBarrier film Spray EUDAMEDCY-NSPY50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060645211372 EUDAMED05060645212171 EUDAMED05060645211648 EUDAMED05060645211341 EUDAMED05060645211655 EUDAMED
- Basic UDI-DI
- 506064521NSUSG01KQ EUDAMED506064521BAC01T7 EUDAMED506064521BASP01WA EUDAMED
- Direct Marketing DI
- 05060645211372 EUDAMED05060645212171 EUDAMED05060645211648 EUDAMED05060645211341 EUDAMED05060645211655 EUDAMED
- EMDN Code
- Z11049085 VARIOUS ULTRASOUND INSTRUMENTS - CONSUMABLES EUDAMEDT0499 INCONTINENCE DEVICES - OTHER EUDAMEDM9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) 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 (5)
- EUDAMED 2d12fc1b-f8f8-4834-af9f-fa591c4e3d58 61 fields · synced Aug 1, 2026
- EUDAMED fdb19df9-c35a-4ad0-9950-73498851b482 61 fields · synced May 17, 2026
- EUDAMED 4cc6c4f3-6c65-4054-aaf6-ad5c15d0e187 61 fields · synced May 18, 2026
- EUDAMED f9a9949e-b2d6-46ae-8a02-ba25edd3ce05 61 fields · synced May 18, 2026
- EUDAMED 3a4c0353-4974-42c9-89eb-931419d09df2 61 fields · synced May 18, 2026