Identity
- Trade Name
- Amielle Care EUDAMED
- Device Name
- Amielle EUDAMED
- Model / Reference
- SM2150SB000 EUDAMEDSM2150EK015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189215116 EUDAMED05016189115010 EUDAMED
- Basic UDI-DI
- 5016189AMIELLENU EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Amielle Care by Owen Mumford 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 | 5016189AMIELLENU | Class I | Active |
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Manufacturer
- Manufacturer
- Owen Mumford Ltd
- EUDAMED SRN
- GB-MF-000021000
- Authorised Representative
- Owen Mumford GmbH DE-AR-000020700
Sources (2)
- EUDAMED 9ed26207-ff9e-4bca-9ea5-3533ea015ed1 61 fields · synced Jul 18, 2026
- EUDAMED 33755a9f-cd67-4794-ab3c-82550967a206 61 fields · synced May 16, 2026