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Non Sterile Single Use Hegar Uterine Dilator Dia 5.0 mm length 185mm
EUDAMEDClass I (EU MDR)
Ref BTEM1050
Identity
- Trade Name
- Non Sterile Single Use Hegar Uterine Dilator Dia 5.0 mm length 185mm EUDAMED
- Device Name
- Non Sterile Single Use Hegar Uterine Dilator Dia 5.0 mm length 185mm EUDAMED
- Model / Reference
- BTEM1050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G075BTEM10500M EUDAMED
- Basic UDI-DI
- B-+G075BTEM10500M EUDAMED
- EMDN Code
- L0509020199 GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Fixed-diameter cervical dilator, reusable
Non Sterile Single Use Hegar Uterine Dilator Dia 5.0 mm length 185mm by Beauty Teck International (Pvt) Ltd — Class I — MDD — listed in EUDAMED
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Also classified as Fixed-diameter cervical dilator, reusable.
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- V. Mueller — STERIS CORPORATION · Class I
- AESCULAP — AESCULAP, INC. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+G075BTEM10500M | Class I | Active |
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Manufacturer
- Manufacturer
- Beauty Teck International (Pvt) Ltd
- EUDAMED SRN
- PK-MF-000009604
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 3650b984-381e-4c72-b003-32183522cc5d 61 fields · synced Jun 18, 2026