Identity
- Trade Name
- E3128 Fogla DMEK Stripping Hook EUDAMED
- Device Name
- Reusable devices EUDAMED
- Model / Reference
- E3128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058935013561 EUDAMED
- Basic UDI-DI
- 4058935-000000-AC EUDAMED
- Direct Marketing DI
- 04058935013561 EUDAMED
- EMDN Code
- L1711 OPHTHALMOLOGY HOOKS, 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
E3128 Fogla DMEK Stripping Hook by Bausch & Lomb GmbH — Class I — 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 | 4058935-000000-AC | Class I | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED e76b30c3-997c-4a87-b901-69f3cabbe99e 61 fields · synced Jul 13, 2026