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CHIRALINE 1, 8x450mm
EUDAMEDClass IIa (EU MDR)
Ref CHL318045Model Extension line
Identity
- Trade Name
- CHIRALINE 1,8x450mm EUDAMED
- Device Name
- Extension line for single use EUDAMED
- Model / Reference
- Extension line EUDAMEDCHL318045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586015048678 EUDAMED
- Basic UDI-DI
- 858601504EXTENLINE14JG EUDAMED
- Direct Marketing DI
- 08586015048678 EUDAMED
- EMDN Code
- A03020101 LOW PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CHIRALINE 1, 8x450mm by CHIRANA T.Injecta, a.s. — 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 | 858601504EXTENLINE14JG | Class IIa | Active |
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Manufacturer
- Manufacturer
- CHIRANA T.Injecta, a.s.
- EUDAMED SRN
- SK-MF-000003702
Sources (1)
- EUDAMED 5ccefad3-62eb-4070-b8ba-42484cf013a0 61 fields · synced Jun 19, 2026