Identity
- Trade Name
- Enopen EUDAMED
- Device Name
- Emollient Creams EUDAMED
- Model / Reference
- ENOPENCREAM500GM EUDAMEDENOPENCREAM150GM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056682200707 EUDAMED05056682200684 EUDAMED
- Basic UDI-DI
- 505668220EmollientsUG EUDAMED
- Direct Marketing DI
- 05056682200707 EUDAMED05056682200684 EUDAMED
- EMDN Code
- M9002 PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Enopen by Ennogen Healthcare International Limited — 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 | 505668220EmollientsUG | Class I | Active |
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Manufacturer
- Manufacturer
- Ennogen Healthcare International Limited
- EUDAMED SRN
- UK-MF-000039877
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (2)
- EUDAMED 51a7c97a-4ec9-444e-ad3a-8fab7dc4d587 61 fields · synced Jul 10, 2026
- EUDAMED 42096ce8-4638-41a5-88c4-788e47c420d0 61 fields · synced May 17, 2026