Identity
- Trade Name
- Hegar Uterine Dilators 19/20mm EUDAMED
- Device Name
- Reusable, Stainless Steel, Non-Sterile Surgical Probes, Dilators and Sounds EUDAMED
- Model / Reference
- RAE-292-19R EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G072RAE29219R0_ EUDAMED
- Basic UDI-DI
- ++G072RUPROBESDILATROS6Y EUDAMED
- Direct Marketing DI
- +G072RAE29219R0_ EUDAMED
- EMDN Code
- L070802 VASCULAR DILATORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Hegar Uterine Dilators 19/20mm by Rhein Enterprises (Pvt) Ltd — 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 | ++G072RUPROBESDILATROS6Y | Class I | Active |
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Manufacturer
- Manufacturer
- Rhein Enterprises (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000036086
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 5fe57270-b1f7-41d5-bd32-fb3b79e8ef44 61 fields · synced Jul 12, 2026