Identity
- Trade Name
- CHIRAFLEX 22G EUDAMED
- Device Name
- Mandrin for single use EUDAMED
- Model / Reference
- Mandrin EUDAMEDCHFX20022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586006512898 EUDAMED
- Basic UDI-DI
- 858601504MANDRIN17J5 EUDAMED
- Direct Marketing DI
- 08586006512898 EUDAMED
- EMDN Code
- A070501 CAPS OR OBTURATORS, NON-PERFORABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Hungary 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
Chiraflex 22g 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 | 858601504MANDRIN17J5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CHIRANA T.Injecta, a.s.
- EUDAMED SRN
- SK-MF-000003702
Sources (1)
- EUDAMED d8ed6ad4-eb4f-4bf0-9c5f-352706e94deb 61 fields · synced Jul 8, 2026