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Aquasoothe 1%
EUDAMEDClass I (EU MDR)
Ref AQUA1CREAM100GRAMRef AQUA1CREAM500GRAM
Identity
- Trade Name
- Aquasoothe 1% EUDAMED
- Device Name
- Emollient Creams EUDAMED
- Model / Reference
- AQUA1CREAM100GRAM EUDAMEDAQUA1CREAM500GRAM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056682200592 EUDAMED05056682200608 EUDAMED
- Basic UDI-DI
- 505668220EmollientsUG EUDAMED
- Direct Marketing DI
- 05056682200592 EUDAMED05056682200608 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
Aquasoothe 1% 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 8b3c6fd8-ec9c-43e7-b68d-0df5f9b54dd1 61 fields · synced Oct 6, 2026
- EUDAMED 4349d676-5e7c-4e0e-a455-dafba0b849c2 61 fields · synced May 18, 2026