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vaginal speculum
EUDAMEDClass I (EU MDR)
Ref HK-A04-M carton OPP GLSMED 100pcs/carton
Identity
- Trade Name
- vaginal speculum EUDAMED
- Device Name
- vaginal speculum EUDAMED
- Model / Reference
- HK-A04-M carton OPP GLSMED 100pcs/carton EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945934603358 EUDAMED
- Basic UDI-DI
- B-16945934603358 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 — CE/MDR — 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-16945934603358 | 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 9d8423d2-5bb4-4243-ac93-890aa3f9e4ef 61 fields · synced Oct 7, 2026
- EUDAMED 1c553246-775e-4292-849e-a5fa0ddf5747 61 fields · synced Jul 10, 2026