Identity
- Device Name
- Urethral Dilator Sets EUDAMED
- Model / Reference
- IVX-TH-2101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950203359020 EUDAMED
- Basic UDI-DI
- 69502033THC6 EUDAMED
- EMDN Code
- U03010201 URETHRAL DILATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Urethral Dilator Sets by Innovex Medical Co., Ltd. — Class IIa — 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 | 69502033THC6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innovex Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000015981
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 0c2eafec-7aad-4d6d-9844-ad0dab997b3c 61 fields · synced Jun 19, 2026