Identity
- Trade Name
- Simcoe Reverse I/A Unit EUDAMED
- Device Name
- Cannula irrigation and or aspiration incl. Accessories EUDAMED
- Model / Reference
- E4971 RG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058935010485 EUDAMED
- Basic UDI-DI
- B-04058935010485 EUDAMED
- EMDN Code
- L1713 OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Simcoe Reverse I/A Unit by Bausch & Lomb GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-04058935010485 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED 233c6e3e-29de-48f8-9495-fa589e6070b7 61 fields · synced Jun 18, 2026