Identity
- Trade Name
- Amielle Comfort EUDAMEDAmielle FDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- Amielle EUDAMEDAmielle Vaginal Dilators FDA UDI
- Model / Reference
- SM2100 EUDAMEDSM 2100 FDA UDI
- Description
- Amielle Vaginal Dilators FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00384702100016 EUDAMEDFDA UDI
- Basic UDI-DI
- 5016189AMIELLENU EUDAMED
- 510(k) Number
- K983045 FDA UDI
- FDA Product Code
- KXP FDA UDI
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
- GMDN Term
- Vaginal dilator FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.3900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 35 Millimeter FDA UDILength — 160 Millimeter FDA UDI
Amielle Comfort by Owen Mumford Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5016189AMIELLENU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 93a887b9-e2f1-475c-b810-5fae456e3d6d 61 fields · synced Jun 19, 2026
- FDA UDI 6f1c6a04-a108-48a0-af36-11e6b4d70b66 37 fields · synced May 30, 2026