Identity
- Trade Name
- Amielle Comfort EUDAMEDAmielle Comfort cone 0 EUDAMED
- Device Name
- Amielle EUDAMED
- Model / Reference
- SM2130SA000 EUDAMEDSM2100EA000 EUDAMEDSM2140SA000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189213013 EUDAMED05016189210012 EUDAMED05016189214010 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 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 (3)
- EUDAMED ccea9cdb-68ff-490a-9f0b-e9f7bfea1651 61 fields · synced Sep 30, 2026
- EUDAMED e5b85ba0-a87b-41f1-8508-576ee27fd51e 61 fields · synced May 18, 2026
- EUDAMED c8944cf2-6ccf-48d1-b05f-07d92cfd4c13 61 fields · synced May 18, 2026