Identity
- Trade Name
- LIBRA EUDAMED
- Device Name
- LIBRA EUDAMED
- Model / Reference
- WSDG-4A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800017600697 EUDAMED
- Basic UDI-DI
- B-08800017600697 EUDAMED
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Intraosseous infusion kit
Libra by Woosung Medi-Filtech — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08800017600697 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Woosung Medi-Filtech
- EUDAMED SRN
- KR-MF-000004529
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 2eb260f5-881f-4f5e-8dac-c589df6e7fd3 61 fields · synced Jun 18, 2026