Identity
- Trade Name
- Bausch + Lomb SimplifEYE™ Inserter EUDAMED
- Device Name
- Inserters EUDAMED
- Model / Reference
- 21984 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00757770566266 EUDAMED
- Basic UDI-DI
- 0310119B1029ZN EUDAMED
- EMDN Code
- Q021111 OCULAR IMPLANT INSTRUMENTS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Bausch + Lomb SimplifEYE™ Inserter by Bausch & Lomb Incorporated — Class IIa — 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 | 0310119B1029ZN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb Incorporated
- EUDAMED SRN
- US-MF-000001029
- Authorised Representative
- Bausch & Lomb GmbH DE-AR-000006810
Sources (1)
- EUDAMED 6466fb39-bcba-447a-a789-89c5ddfd5a71 61 fields · synced Aug 4, 2026