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BAL Flush Spritze 5ml DS
EUDAMEDClass IIa (EU MDR)
Ref 464016Model FL0505SModel BAL Flush Spritze SS
Identity
- Trade Name
- BAL Flush Spritze 5ml DS EUDAMED
- Device Name
- Pre-filled Flush Syringes EUDAMED
- Model / Reference
- FL0505S EUDAMED464016 EUDAMEDBAL Flush Spritze SS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975252958949 EUDAMED
- Basic UDI-DI
- B-06975252958949 EUDAMED697525295PFSNSE EUDAMED
- Direct Marketing DI
- 06975252958949 EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION 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
BAL Flush Spritze 5ml DS by Jiaxing Tianhe Pharmaceutical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial.
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- KLINION — Jiangsu Caina Medical Co.,Ltd. · Class IIa
- Future Generation Medical — Global International L. L. C. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06975252958949 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06975252958949 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiaxing Tianhe Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000042578
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 74278b4e-4ed3-422a-8472-b55245ad2872 61 fields · synced Jun 19, 2026
- EUDAMED 5eeada66-daed-4bb1-a11e-b1dfca0aadcb 61 fields · synced Jun 19, 2026