Identity
- Trade Name
- Uterine Dilators EUDAMED
- Device Name
- Uterine Dilators EUDAMED
- Model / Reference
- UD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08964003662509 EUDAMED
- Basic UDI-DI
- 8964003662UDN4 EUDAMED
- EMDN Code
- U03010202 URETERAL DILATORS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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: Ureteral introduction sheath
Uterine Dilators by CENTRAL SURGICAL Co. (PVT) LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ureteral introduction sheath.
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- Single-use Ureteral Access Sheath — Hunan Vathin Medical Instrument Co., Ltd · Class II
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 | 8964003662UDN4 | Class I | Active |
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Manufacturer
- Manufacturer
- CENTRAL SURGICAL Co. (PVT) LTD.
- EUDAMED SRN
- PK-MF-000035590
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 2fab1cc0-9f1f-4af8-b79d-69112b1593fd 61 fields · synced Jul 9, 2026