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Hyalforte Injection
EUDAMEDClass III (EU MDR)
Ref SPP-B2HPA03T-2201Model HYALFORTE INJECTION
Identity
- Trade Name
- HYALFORTE INJECTION EUDAMED
- Device Name
- HYALFORTE INJECTION EUDAMED
- Model / Reference
- HYALFORTE INJECTION EUDAMEDSPP-B2HPA03T-2201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806103800101 EUDAMED
- Basic UDI-DI
- 880610380010CB EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
Hyalforte Injection by Shin poong Pharm Co., Ltd. — Class III — 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
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- 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
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 | 880610380010CB | Class III | Active |
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Manufacturer
- Manufacturer
- Shin poong Pharm Co., Ltd.
- EUDAMED SRN
- KR-MF-000009206
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (1)
- EUDAMED f80cc503-b157-418e-829a-979852b0fa19 61 fields · synced Oct 6, 2026