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Hegar Uterine Dilators S/E 14.0mm
EUDAMEDClass I (EU MDR)
Ref 60.0350.14Model 60.0010.01
Identity
- Trade Name
- Hegar Uterine Dilators S/E 14.0mm EUDAMED
- Device Name
- Cusco Vaginal Speculum C/Screw 75x17mm virgin EUDAMED
- Model / Reference
- 60.0010.01 EUDAMED60.0350.14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G11360035014AX EUDAMED
- Basic UDI-DI
- ++G113GYNEANDOBSTINSTRUP2 EUDAMED
- EMDN Code
- L0509020102 CERVICAL DILATORS, REUSABLE 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
Hegar Uterine Dilators S/E 14.0mm by Hilbro Instruments (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 | ++G113GYNEANDOBSTINSTRUP2 | Class I | Active |
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Manufacturer
- Manufacturer
- Hilbro Instruments (pvt) Ltd
- EUDAMED SRN
- PK-MF-000023402
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 3e723992-2b9d-44d6-ab43-a55e1b91ebcb 61 fields · synced Sep 30, 2026