Identity
- Trade Name
- Dilators EUDAMED
- Device Name
- Hegar Uterine Dilator D/E set/8, in pouch EUDAMED
- Model / Reference
- 60037000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G11360037000 EUDAMED
- Basic UDI-DI
- ++G11360037000B2 EUDAMED
- EMDN Code
- L0509020101 VAGINAL 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
Dilators 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 | ++G11360037000B2 | 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 2df1def9-35c1-4a54-9bb5-87b692b29b1d 61 fields · synced Jul 22, 2026