Identity
- Trade Name
- SUF03 Phaco Spatula Sterile EUDAMED
- Device Name
- Manipulators, single-use EUDAMED
- Model / Reference
- SUF03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 24058935005140 EUDAMED
- Basic UDI-DI
- 4058935-100000-AV EUDAMED
- EMDN Code
- Q021109 OPHTHALMIC SURGERY SPATULAS, 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
SUF03 Phaco Spatula Sterile 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 | 4058935-100000-AV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED fe13c79b-f486-47d0-9a07-9e46a621a186 61 fields · synced Jul 23, 2026