Identity
- Trade Name
- BAL Flush Spritze 10ml DS EUDAMED
- Device Name
- Pre-filled Flush Syringes EUDAMED
- Model / Reference
- FL1010S EUDAMED464017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975252958956 EUDAMED
- Basic UDI-DI
- B-06975252958956 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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 10ml DS by Jiaxing Tianhe Pharmaceutical Co., Ltd. — Class IIa — 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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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975252958956 | 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 (1)
- EUDAMED dbfdea73-d131-4bc0-a6e4-b3fe95aea275 61 fields · synced Jun 18, 2026