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85912S EA Silicone I/A Handpiece straight
EUDAMEDClass IIa (EU MDR)
Ref 85912S EA
Identity
- Trade Name
- 85912S EA Silicone I/A Handpiece straight EUDAMED
- Device Name
- Irrigation Aspiration Handpieces, sterile for single use EUDAMED
- Model / Reference
- 85912S EA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24058935000381 EUDAMED
- Basic UDI-DI
- 4058935-090000-DZ EUDAMED
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, 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
85912S EA Silicone I/A Handpiece straight by Bausch & Lomb GmbH — 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 | 4058935-090000-DZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED 2b0cb477-1f7b-441d-8706-99f85e1b9b6e 61 fields · synced Jun 19, 2026