Identity
- Trade Name
- Ellele Sampling Device - EPS-03 EUDAMED
- Device Name
- Ellele Sampling Device EUDAMED
- Model / Reference
- EPS-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05070004224400 EUDAMED
- Basic UDI-DI
- 50700042244ESD1BQ EUDAMED
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Ellele Sampling Device - EPS-03 by Ellele Health 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 | 50700042244ESD1BQ | Class I | Active |
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Manufacturer
- Manufacturer
- Ellele Health Limited
- EUDAMED SRN
- UK-MF-000051696
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (1)
- EUDAMED bff35d63-b709-45b0-b72c-bc7a9ba9a75d 61 fields · synced Jul 22, 2026