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vaginal speculum
EUDAMEDClass I (EU MDR)
Ref HK-A06-XXS CARTON INVISIOModel HK-A06-XXS carton OPP INVISIO
Identity
- Trade Name
- vaginal speculum EUDAMED
- Device Name
- vaginal speculum EUDAMED
- Model / Reference
- HK-A06-XXS carton OPP INVISIO EUDAMEDHK-A06-XXS CARTON INVISIO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16945934604881 EUDAMED
- Basic UDI-DI
- B-16945934604881 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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-16945934604881 | 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 (1)
- EUDAMED 86578a9c-9d2c-47d5-b8b0-664dc5bc8216 61 fields · synced Jun 14, 2026