Identity
- Trade Name
- 54270Y4 Spatula EUDAMED
- Device Name
- Reusable devices EUDAMED
- Model / Reference
- 54270Y4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058935007775 EUDAMED
- Basic UDI-DI
- 4058935-000000-AC EUDAMED
- Direct Marketing DI
- 04058935007775 EUDAMED
- EMDN Code
- L1706 OPHTHALMOLOGY SPATULAS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Ocular hook/spatula/manipulator, reusable
54270Y4 Spatula by Bausch & Lomb GmbH — Class I — 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 | 4058935-000000-AC | Class I | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED 3527119f-e4f5-4d42-945b-b091238b26bb 61 fields · synced Jul 8, 2026