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Klinion
EUDAMEDClass IIa (EU MDR)
Ref C0880368Model PP02 seriesRef C0880205Model NA
Identity
- Trade Name
- KLINION EUDAMED
- Device Name
- Pre-Filled Syringe with Saline EUDAMEDDisposable Safety Hypodermic Needles EUDAMED
- Model / Reference
- PP02 series EUDAMEDC0880368 EUDAMEDNA EUDAMEDC0880205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564462945 EUDAMED06971564463188 EUDAMED
- Basic UDI-DI
- 69715644600341ZW EUDAMED69715644600170ZT EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMEDA0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial
Klinion by Jiangsu Caina Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial.
- BAL Flush Spritze 10ml DS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-fillefd flush syringe(B001-MY) — Jiangsu Embrace Science&Technology Development Co., Ltd. · Class IIa
- BAL Flush Spritze 5ml SS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
- Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp. · Class II
- Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class II
- EASY FLUSH — SPM MEDICARE PVT, LTD. · Class IIb
- Prefilled Syringe with 0.9% Saline Solution — Poly Medicure Limited · Class IIb
- Future Generation Medical — Global International L. L. C. · Class II
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 | 69715644600341ZW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 95a0c0ab-b25a-4a1f-9635-1bb90e198be3 61 fields · synced Jul 24, 2026
- EUDAMED 9a61a8d3-ec09-45d1-aa87-19b574a1aa1c 61 fields · synced May 16, 2026