Identity
- Device Name
- Small Parts Kit (Bulk Non-Sterile) EUDAMED
- Model / Reference
- 8065750353 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00380657503537 EUDAMED
- Basic UDI-DI
- 038065GMN000300GS EUDAMED
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
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
Category: Phacoemulsification system handpiece tip, single-use
Small Parts Kit (Bulk Non-Sterile) by Alcon Laboratories, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 038065GMN000300GS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
- EUDAMED SRN
- US-MF-000016248
- Authorised Representative
- Alcon Laboratories Belgium BE-AR-000014721
Sources (1)
- EUDAMED f6bf6b1e-0d2d-4dcc-baee-3276c4b77998 61 fields · synced Jun 18, 2026