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BAL Flush Spritze 10ml SS
EUDAMEDClass IIa (EU MDR)
Ref 464013Model FL1010NModel BAL Flush Spritze SS
Identity
- Trade Name
- BAL Flush Spritze 10ml SS EUDAMED
- Device Name
- Pre-filled Flush Syringe EUDAMEDPre-filled Flush Syringes EUDAMED
- Model / Reference
- FL1010N EUDAMED464013 EUDAMEDBAL Flush Spritze SS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975252958925 EUDAMED
- Basic UDI-DI
- B-06975252958925 EUDAMED697525295PFSNSE EUDAMED
- Direct Marketing DI
- 06975252958925 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
BAL Flush Spritze 10ml SS by Jiaxing Tianhe Pharmaceutical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975252958925 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06975252958925 | 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 4f36339b-397f-413f-81e4-a0049b40fdcc 61 fields · synced Jun 20, 2026
- EUDAMED 0fc7ff4e-aa66-4b4f-a192-f02cbec06abd 61 fields · synced Jun 20, 2026