Identity
- Trade Name
- Instramed Sound Dilator EUDAMED
- Device Name
- Sterile Surgical Kits for Intrauterine Contraception Operation 无菌宫内节育包 EUDAMED
- Model / Reference
- HY-0350 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16942013200583 EUDAMED
- Basic UDI-DI
- 697023378IUCDkitsTB EUDAMED
- Direct Marketing DI
- 06942013200586 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Instramed Sound Dilator by Hubei V-Medical Products Co., 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 | 697023378IUCDkitsTB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hubei V-Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000011268
- Authorised Representative
- RAFFIN MEDICAL FR-AR-000004632
Sources (1)
- EUDAMED 1f3d76e2-b4d6-4ee3-8e49-a2443e191213 61 fields · synced Jul 20, 2026