Identity
- Device Name
- Uterine Dilator sets EUDAMED
- Model / Reference
- Uterine Dilator sets EUDAMED
Identifiers
- Primary DI / UDI-DI
- 111823022608 EUDAMED
- Basic UDI-DI
- PP12633UTERINEDILATOR04 EUDAMED
- Direct Marketing DI
- 111823022608 EUDAMED
- EMDN Code
- L0509020199 GYNECOLOGICAL USE DILATORS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria 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 Dilator sets by Qureshi Manufacturing Corporation — 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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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 | PP12633UTERINEDILATOR04 | Class I | Active |
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Manufacturer
- Manufacturer
- Qureshi Manufacturing Corporation
- EUDAMED SRN
- PK-MF-000024744
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (1)
- EUDAMED dc36f6dd-1fe6-4fcb-8f6a-127416e088ab 61 fields · synced Jun 19, 2026