Identity
- Trade Name
- Uterine Dilators EUDAMED
- Device Name
- Uterine Dilators EUDAMED
- Model / Reference
- 11-152 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964004479724 EUDAMED
- Basic UDI-DI
- 89640031763307N EUDAMED
- EMDN Code
- L0509020199 GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Category: Fixed-diameter cervical dilator, reusable
Uterine Dilators by Formed Surgical Instruments — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Fixed-diameter cervical dilator, reusable.
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- 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 | 89640031763307N | Class I | Active |
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Manufacturer
- Manufacturer
- Formed Surgical Instruments
- EUDAMED SRN
- PK-MF-000011695
- Authorised Representative
- International Business Compendious of Sweden SE-AR-000001625
Sources (1)
- EUDAMED fb89481d-5f65-41ca-acb5-5edf16a23c40 61 fields · synced Jul 9, 2026