Identity
- Trade Name
- Handpiece for US3170 Standard Sleeve EUDAMED
- Device Name
- Single Use Handpiece for Ultrasonic Element for Phacoemulsification EUDAMED
- Model / Reference
- SUH5501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24058935010939 EUDAMED
- Basic UDI-DI
- B-24058935010939 EUDAMED
- EMDN Code
- Q020601 PHACOEMULSIFICATION SETS 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
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
Handpiece for US3170 Standard Sleeve by Bausch & Lomb GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-24058935010939 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED c191f354-3b09-4d57-9f0f-04de978d03d7 61 fields · synced Jul 16, 2026