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CHIRANA 1ml Luer
EUDAMEDClass IIa (EU MDR)
Ref CH03001LModel Hypodermic syringeRef CHTUB01Model Tuberculin syringe
Identity
- Trade Name
- CHIRANA 1ml Luer EUDAMED
- Device Name
- Sterile hypodermic syringe for single use EUDAMEDSterile tuberculin syringe for single use EUDAMED
- Model / Reference
- Hypodermic syringe EUDAMEDCH03001L EUDAMEDTuberculin syringe EUDAMEDCHTUB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586015044441 EUDAMED08586015045158 EUDAMED
- Basic UDI-DI
- 858601504SYRINGE0159 EUDAMED858601504TUBERCULIN04LN EUDAMED
- Direct Marketing DI
- 08586015044441 EUDAMED08586015045158 EUDAMED
- EMDN Code
- A020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMEDA020109 TUBERCULIN SYRINGES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMEDDenmark 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 1ml Luer 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 (2)
- EUDAMED 8772ba04-8b17-4e8f-be0f-4fc02969c1fc 61 fields · synced Jul 18, 2026
- EUDAMED c3958b25-fbcb-483b-a33f-252babccc3e1 61 fields · synced Jul 12, 2026