Identity
- Trade Name
- HEGAR uterus dilator 11,0mm ,S/S EUDAMED
- Device Name
- HEGAR uterus dilator 11,0mm ,S/S EUDAMED
- Model / Reference
- 7041011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G47270410110 EUDAMED
- Basic UDI-DI
- ++G47270414011KP 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 uterus dilator 11, 0mm , S/S by HB Meditech (Pvt) Limited — 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 | ++G47270414011KP | Class I | Active |
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Manufacturer
- Manufacturer
- HB Meditech (Pvt) Limited
- EUDAMED SRN
- PK-MF-000024590
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED cd869a9f-fc37-49d2-a6be-eb781a45d02a 61 fields · synced Jul 14, 2026