Identity
- Device Name
- Sterile Lubricating Jelly EUDAMED
- Model / Reference
- 53J805-5001-000A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290100663301 EUDAMED
- Basic UDI-DI
- B-07290100663301 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Lubricating Jelly by Sion Biotext Medical Ltd — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07290100663301 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sion Biotext Medical Ltd.
- EUDAMED SRN
- IL-MF-000012169
- Authorised Representative
- Theo Manufacturing B.V. NL-AR-000006691
Sources (1)
- EUDAMED b614b95e-5851-4487-892b-7a29e994ba46 61 fields · synced Jun 19, 2026