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4504-02 : Active/Passive Backflush Handle + 25g x 1 1/4" (0.5 x 32mm) Soft Tip …
EUDAMEDClass IIa (EU MDR)
Ref 4504-02
Identity
- Device Name
- 4504-02 : Active/Passive Backflush Handle + 25g x 1 1/4" (0.5 x 32mm) Soft Tip Cannula EUDAMED
- Model / Reference
- 4504-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-25056030403020C7 EUDAMED
- Basic UDI-DI
- B-25056030403020C7 EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
4504-02 : Active/Passive Backflush Handle + 25g x 1 1/4" (0.5 x 32mm) Soft Tip … by Sterimedix Ltd — Class IIa — MDD — listed in EUDAMED
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- Universal PVC infusion line for 23G cannula system for VFI/VFE — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Soft Tip Cannula 20g, 0.8mm tip — Psi/Eye-Ko, Inc. · Class IIa
- I/A HDP. 45 W SLEEVE 1.8 12/BX — Bausch & Lomb, Inc. · Class II
- Visitec® — Beaver-Visitec International, Inc. · Class I
- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
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-25056030403020C7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sterimedix Ltd
- EUDAMED SRN
- GB-MF-000011604
- Authorised Representative
- Bausch & Lomb GmbH DE-AR-000006810
Sources (1)
- EUDAMED 41ff7125-c225-47ea-9084-e4d29c94174f 61 fields · synced Jun 18, 2026