Identity
- Device Name
- Small Parts Kit (Bulk Non-Sterile) EUDAMED
- Model / Reference
- 8065750765 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00380657507658 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
Small Parts Kit (Bulk Non-Sterile) by Alcon Laboratories, Inc. — 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 | 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 5d4d7c0c-3868-4812-8bef-f9267ad57b2d 61 fields · synced Jun 19, 2026