Identity
- Trade Name
- Sensitex Lubricant Monodose 3.5ml EUDAMED
- Device Name
- Packaged water based lubricant EUDAMED
- Model / Reference
- QA-279 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09556807371917 EUDAMED29556807371904 EUDAMED
- Basic UDI-DI
- 9556807LB001X4 EUDAMED
- Direct Marketing DI
- 09556807371917 EUDAMED29556807371904 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Spain 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
Sensitex Lubricant Monodose 3.5ml by Richter Rubber Technology Sdn. Bhd. — Class IIb — 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 | 9556807LB001X4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Richter Rubber Technology Sdn Bhd
- EUDAMED SRN
- MY-MF-000023324
- Authorised Representative
- rrt Vertrieb und Service GmbH DE-AR-000021443
Sources (2)
- EUDAMED a336ed3f-fccb-4bb9-81c7-c35ab41d0c09 61 fields · synced Jul 9, 2026
- EUDAMED 5bf7a8d7-f73c-4f2f-a77d-954f8f10d3e2 61 fields · synced May 17, 2026