Identity
- Trade Name
- Enopen 1050g EUDAMED
- Device Name
- Thirty:30 125g EUDAMED
- Model / Reference
- Thirty:30 125g EUDAMEDENOPENCREAM1050GM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060254922461 EUDAMED
- Basic UDI-DI
- 506025492EmollientsP3 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
- Northern 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 1050g by Ennogen Healthcare 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 | 506025492EmollientsP3 | Class I | Active |
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Manufacturer
- Manufacturer
- Ennogen Healthcare Ltd
- EUDAMED SRN
- GB-MF-000022280
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (1)
- EUDAMED 1be60bc0-16b2-46f2-9ee8-df7a72da928f 61 fields · synced Jun 18, 2026