Identity
- Trade Name
- Women Care EUDAMED
- Device Name
- Vaginitis treatment device EUDAMED
- Model / Reference
- CHD-5000 EUDAMEDML-5000-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800154400082 EUDAMED
- Basic UDI-DI
- B-08800154400082 EUDAMED
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Women Care by SJ Global Co., Ltd. — Class IIa — 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-08800154400082 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SJ Global Co., Ltd.
- EUDAMED SRN
- KR-MF-000012446
- Authorised Representative
- JaviTech e.K. DE-AR-000005875
Sources (1)
- EUDAMED 70e26fcd-08e4-4d98-ae77-97421a5bb9c4 61 fields · synced Jun 19, 2026