Identity
- Trade Name
- vaginal speculum EUDAMED
- Device Name
- vaginal speculum EUDAMED
- Model / Reference
- HK-A04-M single bag OPP GLSMED EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945934603351 EUDAMED
- Basic UDI-DI
- B-06945934603351 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMEDPortugal EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
vaginal speculum by Changzhou Huankang Medical Device Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06945934603351 | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Huankang Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000009030
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED b367b344-458b-43dc-9b8d-81f66cc4fd5e 61 fields · synced Jun 18, 2026
- EUDAMED 3b884ece-6bde-4d9d-a294-2827aa71b836 61 fields · synced Jun 18, 2026