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Unico Xl - Percutaneous Kit Ch12
EUDAMEDClass IIa (EU MDR)
Ref 10821Model 10800
by Redax S.p.A.
Identity
- Trade Name
- UNICO XL - PERCUTANEOUS KIT CH12 EUDAMED
- Device Name
- UNICO - PERCUTANEOUS KIT CH 9 EUDAMED
- Model / Reference
- 10800 EUDAMED10821 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034139296548 EUDAMED
- Basic UDI-DI
- 803413929UNICO1aRF EUDAMED
- EMDN Code
- A060204 THORACENTESIS AND PARACENTESIS DRAINAGES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Unico Xl - Percutaneous Kit Ch12 by Redax S.p.A. — Class IIa — 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 | 803413929UNICO1aRF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Redax S.p.A.
- EUDAMED SRN
- IT-MF-000019320
Sources (1)
- EUDAMED 2db12290-c5b6-458f-aed8-e3e1872d8ab8 61 fields · synced Jul 10, 2026