Identity
- Trade Name
- Oui Labs EUDAMED
- Device Name
- Fixed Diameter Cervical Dialator EUDAMED
- Model / Reference
- UPC 850013300501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850013300501 EUDAMED
- Basic UDI-DI
- 850013300VW0005UG EUDAMED
- EMDN Code
- L0509020102 CERVICAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Oui Labs by Oui Labs — 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 | 850013300VW0005UG | Class I | Active |
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Manufacturer
- Manufacturer
- Oui Labs
- EUDAMED SRN
- US-MF-000039663
- Authorised Representative
- Global E-commerce Experts Europe BV NL-AR-000038301
Sources (1)
- EUDAMED 35225987-61da-4cda-9796-5e77896fb666 61 fields · synced Jul 24, 2026