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VWELL InMotion Dilator Exerciser Trainer Set
EUDAMEDClass I (EU MDR)
Ref INT-VW0010Model INT-VW0010
by Oui Labs
Identity
- Device Name
- VWELL InMotion Dilator Exerciser Trainer Set EUDAMED
- Model / Reference
- INT-VW0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810085170044 EUDAMED
- Basic UDI-DI
- 081008517VW0010X5 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 InMotion Dilator Exerciser Trainer 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 | 081008517VW0010X5 | 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 37190a88-5097-4c92-8f76-f43f88efcfd2 61 fields · synced Jun 18, 2026