Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Vaginal dilator FDA UDI
- Device Name
- Uterus dilator EUDAMEDHEGAR Uterine Dilator, 7 1/4", (185 mm), diam. 25 mm, very conical tip, non-sterile, reusable FDA UDI
- Model / Reference
- EM125R EUDAMEDFDA UDI
- Description
- HEGAR Uterine Dilator, 7 1/4", (185 mm), diam. 25 mm, very conical tip, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- EM125R FDA UDI
- Primary DI / UDI-DI
- 04038653154012 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000006602F EUDAMED
- Direct Marketing DI
- 04038653154012 EUDAMED
- FDA Product Code
- HDQ FDA UDI
- EMDN Code
- L0509020199 GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Vaginal dilator FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fixed-diameter cervical dilator, reusable
Aesculap by Aesculap AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixed-diameter cervical dilator, reusable.
- Surgical — TIMESCO HEALTHCARE LIMITED · Class I
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- 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 (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 40392390000006602F | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 0e09e61d-f77b-4e3c-82c2-5b891b28f0be 61 fields · synced Jul 13, 2026
- FDA UDI 1c4655bb-8d72-4f7c-b7c6-ba17493eb79e 35 fields · synced May 30, 2026