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Pre-filled syringe 0.9% Sodium Chloride (0.9% NaCl)
EUDAMEDClass IIb (EU MDR)
Ref 90326Model Prefilled Syringe with 0.9% Saline Solution
Identity
- Trade Name
- Pre-filled syringe 0.9% Sodium Chloride (0.9% NaCl) EUDAMED
- Device Name
- Prefilled Syringe with 0.9% Saline Solution EUDAMED
- Model / Reference
- Prefilled Syringe with 0.9% Saline Solution EUDAMED90326 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095903261 EUDAMED
- Basic UDI-DI
- 890209590315GJ EUDAMED
- EMDN Code
- A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Croatia 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
Pre-filled syringe 0.9% Sodium Chloride (0.9% NaCl) by Poly Medicure Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 890209590315GJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043011
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 4bea2489-b4a8-42a5-bf8c-3cfb9a2c89ba 61 fields · synced Jul 19, 2026