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CHIRANA 2ml Luer 2-part
EUDAMEDClass IIa (EU MDR)
Ref CH002LModel Hypodermic syringe
Identity
- Trade Name
- CHIRANA 2ml Luer 2-part EUDAMED
- Device Name
- Sterile hypodermic syringe for single use EUDAMED
- Model / Reference
- Hypodermic syringe EUDAMEDCH002L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586015041372 EUDAMED
- Basic UDI-DI
- 858601504SYRINGE0159 EUDAMED
- Direct Marketing DI
- 08586015041372 EUDAMED
- EMDN Code
- A020102010102 INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE 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
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CHIRANA 2ml Luer 2-part 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 | 858601504SYRINGE0159 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CHIRANA T.Injecta, a.s.
- EUDAMED SRN
- SK-MF-000003702
Sources (1)
- EUDAMED bd0e812f-ed21-428b-8989-1aa4b5726719 61 fields · synced Jun 18, 2026