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VWELL Flex Pelvic Floor Muscle Relaxer
EUDAMEDClass I (EU MDR)
Ref INT-VW0008
by Oui Labs
Identity
- Device Name
- VWELL Flex Pelvic Floor Muscle Relaxer EUDAMED
- Model / Reference
- INT-VW0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850013300976 EUDAMED
- Basic UDI-DI
- 0850013300VW0008JA EUDAMED
- EMDN Code
- U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER 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 Flex Pelvic Floor Muscle Relaxer 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 | 0850013300VW0008JA | 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 d6073684-181c-4a82-9e3c-1f2e29a42cb4 61 fields · synced Jul 28, 2026