← Back to catalogue
Vaginal/Cervical Dilator
EUDAMEDClass I (EU MDR)
Ref DCL, DCSModel Small and Large
Identity
- Trade Name
- Vaginal/Cervical Dilator EUDAMED
- Device Name
- Vaginal Dilator EUDAMED
- Model / Reference
- Small and Large EUDAMEDDCL, DCS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906028600517 EUDAMED
- Basic UDI-DI
- 890602860SMBVDK9 EUDAMED
- EMDN Code
- U1080 OBSTETRICS DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Vaginal/Cervical Dilator by SMB Corporation of India — 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 | 890602860SMBVDK9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SMB Corporation of India
- EUDAMED SRN
- IN-MF-000023742
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 8f285bd1-9b0b-4ec9-8d9d-c84ff303b824 61 fields · synced Jun 19, 2026
- EUDAMED 8f285bd1-9b0b-4ec9-8d9d-c84ff303b824-1 61 fields · synced Jun 10, 2026