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VWELL Super Fit Extra Large Dilator Set
EUDAMEDClass I (EU MDR)
Ref INT-VW0006
by Oui Labs
Identity
- Device Name
- VWELL Super Fit Extra Large Dilator Set EUDAMED
- Model / Reference
- INT-VW0006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850013300952 EUDAMED
- Basic UDI-DI
- 0850013300VW0006J6 EUDAMED
- EMDN Code
- L0509020101 VAGINAL 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
VWELL Super Fit Extra Large Dilator Set 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 | 0850013300VW0006J6 | 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 796dc0ad-3301-4ad0-81d9-511650712cd6 61 fields · synced Jul 20, 2026