Identity
- Trade Name
- Vaginal speculum EUDAMED
- Device Name
- Vaginal speculum EUDAMED
- Model / Reference
- HA05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970908501067 EUDAMED06970908501050 EUDAMED06970908501074 EUDAMED26970908501085 EUDAMED06970908501043 EUDAMED26970908501047 EUDAMED
- Basic UDI-DI
- 697090850ha05SP 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
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
Vaginal speculum by Hoshin Medical Instrument 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 | 697090850ha05SP | Class I | Active |
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Manufacturer
- Manufacturer
- Hoshin Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000003898
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 693c3e27-2e28-4336-bf44-49107d64b480 61 fields · synced Oct 6, 2026
- EUDAMED 942c6f3e-38ba-40d9-8b93-157bee73ddd4 61 fields · synced May 17, 2026
- EUDAMED 31d54fb0-fa38-4168-8491-3961fcd24b72 61 fields · synced May 17, 2026
- EUDAMED 9bfe3ac3-3e1d-47e3-83af-87877366daab 61 fields · synced May 18, 2026
- EUDAMED 59aaabc6-d721-437a-b5af-b5b407b8c429 61 fields · synced May 19, 2026
- EUDAMED 35175edf-242a-4412-be30-9143449a09bf 61 fields · synced May 19, 2026