Identity
- Trade Name
- Xenamed Industries EUDAMED
- Device Name
- UTERINE DILATORS EUDAMED
- Model / Reference
- 170-025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G2371700250+ EUDAMED
- Basic UDI-DI
- ++G237UterineDilatorsCX EUDAMED
- EMDN Code
- L0509020199 GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Category: Fixed-diameter cervical dilator, reusable
Xenamed Industries by Xenamed Industries — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-diameter cervical dilator, reusable.
- Surgical — TIMESCO HEALTHCARE LIMITED · Class I
- Hegar méhnyak tágító, enyhén kúpos heggyel, d= 3 mm, 180 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Kleegman Stainless Steel Dilator — MEDGYN PRODUCTS, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Galabins méhszonda, d= 3, 6 mm, 295 mm — SUBAN Kéziműszer Hungary Zártkörűen Működő Részvénytársaság · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- AESCULAP — AESCULAP, INC. · Class I
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 | ++G237UterineDilatorsCX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xenamed Industries
- EUDAMED SRN
- PK-MF-000037495
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 923c4dd8-9927-4466-94f4-dd3734bf53d5 61 fields · synced Jun 18, 2026