Identity
- Trade Name
- SUP06 Zero Phaco Handpiece II, 2.2 mm EUDAMED
- Device Name
- Irrigation Aspiration Handpieces, sterile for single use EUDAMED
- Model / Reference
- SUP06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24058935005867 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
SUP06 Zero Phaco Handpiece II, 2.2 mm 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 0a63389e-b92d-47fe-88f7-5683f536b59b 61 fields · synced Jul 9, 2026