Identity
- Device Name
- Lee’s Cerclage Balloon EUDAMED
- Model / Reference
- AI-004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809157678139 EUDAMED
- Basic UDI-DI
- B-08809157678139 EUDAMED
- EMDN Code
- U080199 GYNAECOLOGICAL CATHETERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Lee’s Cerclage Balloon by Yushin Medical 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-08809157678139 | Class I | Active |
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Manufacturer
- Manufacturer
- Yushin Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000010526
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (1)
- EUDAMED 46d110e4-9ed2-4d69-9655-f7ae401f5b15 61 fields · synced Jul 10, 2026