Identity
- Trade Name
- Kratz-Barraquer eye speculum EUDAMED
- Device Name
- Eye Speculum EUDAMED
- Model / Reference
- 52121K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04058935007348 EUDAMED
- Basic UDI-DI
- B-04058935007348 EUDAMED
- EMDN Code
- L17010199 OCULAR DILATORS, REUSABLE - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Kratz-Barraquer eye speculum by Bausch & Lomb GmbH — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04058935007348 | Class I | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb GmbH
- EUDAMED SRN
- DE-MF-000009142
Sources (1)
- EUDAMED f4cab265-5a2e-4cb3-96bc-521b4c9365ce 61 fields · synced Jul 9, 2026