Identity
- Trade Name
- CHIRAFLEX 18G EUDAMED
- Device Name
- Scalp vein set for single use EUDAMED
- Model / Reference
- Scalp vein set EUDAMEDCH260001118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586015041020 EUDAMED
- Basic UDI-DI
- 858601504SCALPVEINSET16T5 EUDAMED
- Direct Marketing DI
- 08586015041020 EUDAMED
- EMDN Code
- A01010202 BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS 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
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
Chiraflex 18g 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 | 858601504SCALPVEINSET16T5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CHIRANA T.Injecta, a.s.
- EUDAMED SRN
- SK-MF-000003702
Sources (1)
- EUDAMED f9f80594-eaf6-4b09-bc7b-8456fe39823e 61 fields · synced Jul 11, 2026