Identity
- Trade Name
- Gynecological skirt EUDAMED
- Device Name
- Gynecological skirt EUDAMED
- Model / Reference
- UM-GS-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973490854948 EUDAMED16973490854945 EUDAMED
- Basic UDI-DI
- 697349085GS4L EUDAMED
- Direct Marketing DI
- 06973490854948 EUDAMED16973490854945 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
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
Gynecological skirt by Unimax Medical Products 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 | 697349085GS4L | Class I | Active |
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Manufacturer
- Manufacturer
- Unimax Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000017381
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 974e72e4-490c-44cd-9d37-b23967a00522 61 fields · synced Oct 9, 2026
- EUDAMED 69ba0403-4a80-4ad9-816f-85bd57ba59f5 61 fields · synced May 18, 2026