← Back to catalogue
BAL Flush Spritze 3ml SS
EUDAMEDClass IIa (EU MDR)
Ref BAL360602001Model FL0303NRef 464011Model FL0305NModel BAL Flush Spritze SS
Identity
- Trade Name
- BAL Flush Spritze 3ml SS EUDAMED
- Device Name
- Pre-filled Flush Syringes EUDAMEDPre-filled Flush Syringe EUDAMED
- Model / Reference
- FL0303N EUDAMEDBAL360602001 EUDAMEDFL0305N EUDAMED464011 EUDAMEDBAL Flush Spritze SS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937404203079 EUDAMED06975252958901 EUDAMED
- Basic UDI-DI
- B-06937404203079 EUDAMEDB-06975252958901 EUDAMED697525295PFSNSE EUDAMED
- Direct Marketing DI
- 06937404203079 EUDAMED06975252958901 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 3ml SS 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.
- Pre-fillefd flush syringe(B001-MY) — Jiangsu Embrace Science&Technology Development Co., Ltd. · Class IIa
- Burg Pharma — Jiangsu Caina Medical 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
- 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-06937404203079 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06937404203079 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiaxing Tianhe Pharmaceutical Co., Ltd.
- EUDAMED SRN
- CN-MF-000042578
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED b93e2b43-e9d8-48e5-9af9-caedf9f4d78e 61 fields · synced Aug 2, 2026
- EUDAMED de50d548-011f-4c74-9ac0-5c084a829c1c 61 fields · synced May 16, 2026
- EUDAMED 0f0d0851-de4f-41ad-97c3-9dce97703c44 61 fields · synced Jul 9, 2026
- EUDAMED 60ab30bb-9ce5-4075-b240-970e8c990f78 61 fields · synced Aug 2, 2026