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vaginal speculum
EUDAMEDClass I (EU MDR)
Ref HK-A06-XS carton Blister Medplus 50pcs/carton
Identity
- Trade Name
- vaginal speculum EUDAMED
- Device Name
- vaginal speculum EUDAMED
- Model / Reference
- HK-A06-XS carton Blister Medplus 50pcs/carton EUDAMED
Identifiers
- Primary DI / UDI-DI
- 36945934603185 EUDAMED
- Basic UDI-DI
- B-36945934603185 EUDAMED
- EMDN Code
- U089006 VAGINAL SPECULUM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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-36945934603185 | 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 bbd7835c-f91f-4fc9-ba9c-6f42d595f0bc 61 fields · synced Oct 5, 2026