Identity
- Trade Name
- Pelvimed Dilator Gr.5 EUDAMED
- Device Name
- Pelvimed Dialator Gr.5 EUDAMED
- Model / Reference
- MED1002648-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250201226419 EUDAMED
- Basic UDI-DI
- 425020122641ZF EUDAMED
- EMDN Code
- L0509020101 VAGINAL DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Pelvimed Dilator Gr.5 by medesign I.C. GmbH — 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 | 425020122641ZF | Class I | Active |
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Manufacturer
- Manufacturer
- medesign I.C. GmbH
- EUDAMED SRN
- DE-MF-000020677
Sources (1)
- EUDAMED 5c09cdd0-3baf-4e38-b0c4-0984e4e6bb55 61 fields · synced Jun 18, 2026